WARNING LETTERDynamic Stem Cell TherapyMARCS-CMS 712579 —February 11, 2026Delivery Method:VIA UPS and Electronic MailReference #:CBER 25-712579Product:BiologicsRecipient:Dale Carrison, D.O., FACEP, FACOEPMedical DirectorDynamic Stem Cell Therapy2551 N. Green Valley ParkwayBuilding C, Suite 305CHenderson,NV89014United StatesContact@stemcellpowernow.comIssuing Office:Center for Biologics Evaluation and ResearchUnited StatesWARNING LETTERFebruary 11, 2026CBER 25-712579Dear Dr. Carrison:The United States Food and Drug Administration (FDA) reviewed your company’s website at https://stemcellpowernow.com (last visited February 2026), through which your company markets an umbilical cord-derived stem cell product for allogeneic use (hereinafter, “your umbilical-cord derived product”).This letter is to advise you that your misbranding of your umbilical-cord derived product while held for sale after shipment in interstate commerce violates section 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(k).Unapproved New Drug and Unlicensed Biological Product ViolationsBased on information and records reviewed by FDA, https://stemcellpowernow.com (last visited February 2026), your umbilical-cord derived product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example, you make the following claims about stem cells (which you state are used to make your umbilical-cord derived product):Under a title of Regenerative Medicine for Sports Injuries, “There are a number of different types of sports injuries that can be treated with stem cells, including:o Knee injuries such as ligament tears and cartilage damageo Shoulder injuries such as rotator cuff tears and bursitiso Ankle and foot injuries such as ankle sprains and Achilles tendon ruptureso Hip injuries such as hip labral tears and arthritiso Muscle strains and tears”Under a title of Anti-Aging Stem Cell Therapy, “Anti-aging isn't the only amazing thing stem cell therapy can do--it has also been shown to improve various conditions resulting from injuries, like knee pain, spinal cord injury, joint pain, cardiovascular disease, and arthritis.”Therefore, your umbilical-cord derived product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(i).Your umbilical-cord derived product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, Dynamic Stem Cell Therapy does not qualify for any exception in 21 CFR 1271.15, and your umbilical-cord derived product fails to meet all criteria in 21 CFR 1271.10(a).For example, your umbilical-cord derived product fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1), because your processing alters the original relevant characteristics of the umbilical cord related to its utility for reconstruction, repair, or replacement. The processing of the umbilical cord from the form of a conduit into an injectable form, significantly alters the physical state of the HCT/P. The umbilical cord is more than minimally manipulated because such processing alters the original relevant characteristics of the HCT/P relating to its utility to serve as a conduit by effectively altering or eliminating its physical integrity and tubular form.In addition, your umbilical-cord derived product fails to meet the criterion that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor” (21 CFR 1271.3(c) and 1271.10(a)(2)). Your umbilical-cord derived product is not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., serving as a conduit). Rather, your umbilical-cord derived product is intended for use in the treatment of cardiovascular disease or arthritis, for example, which is not a basic function of the human umbilical cord in the donor.Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.1See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your umbilical-cord derived product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.Your umbilical-cord derived product is a misbranded drug under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). A drug is misbranded under section 502(f)(1) if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. 21 CFR 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.Your umbilical-cord derived product is intended for use in the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your umbilical-cord derived product safely for its intended purposes. Accordingly, your umbilical-cord derived product fails to bear adequate directions for its intended uses and, therefore, is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). Misbranding your umbilical-cord derived product while it is held for sale after shipment of the drug or one or more of its components in interstate commerce is prohibited under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).Your umbilical-cord derived product is not the subject of an approved biologics license application (BLA) under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. If your umbilical-cord derived product was the subject of an approved BLA and labeled consistent with the approval, it would bear adequate directions for its intended uses, and subject to exceptions not applicable here, it could be lawfully introduced or delivered for introduction into interstate commerce.Additional ConcernIn addition to the violations described above, we offer the following comment:FDA’s review of your website also found that you market exosomes. As a general matter, exosomes intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body are subject to requirements for drugs, as defined in section 201(g)(1) of the FD&C Act, and biological products under section 351 of the PHS Act, including applicable premarket review and approval requirements. We also direct your attention to FDA’s Public Safety Notification on Exosome Products, available at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products. FDA issued this public safety notification following multiple reports of serious adverse events experienced by patients who were treated with exosome products.ConclusionThis letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your umbilical-cord derived product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with the FD&C Act, PHS Act, and all applicable regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your umbilical-cord derived product is in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research___________________1Because your umbilical-cord derived product fails to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).

WARNING LETTERExThera Medical CorporationMARCS-CMS 715068 —February 06, 2026Product:Medical DevicesRecipient:Erin R. BorgerChief Executive Officer (CEO)ExThera Medical Corporation757 Arnold Drive, Suite BMartinez,CA94553United States(b)(4)@extheramedical.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERFebruary 06, 2026Dear Mr. Borger:This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at ExThera Medical Corporation (ExThera) from May 27, 2025, to June 4, 2025, by an investigator from the FDA’s Office of Bioresearch Monitoring Inspectorate (OBMI). This inspection was conducted to determine whether your activities and procedures as a sponsor in the significant risk clinical studies, “Blood Purification for the Treatment of Critically Ill Patients with Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial (Purify Study),” for Seraph 100 Microbind Affinity Blood Filter, Investigational Device Exemption (IDE), G210074, and “Prospective Single-Arm Feasibility Study to Determine the Capacity of the Onco-Seraph 100 Microbind Affinity Blood Filter (Onco-Seraph 100) to Remove Circulating Tumor Cells from the Blood of Patients with Metastatic Pancreatic Ductal Adenocarcinoma (Oscar Study),” for Onco-Seraph 100, IDE, G230144, complied with applicable federal regulations.The Seraph 100 Microbind Affinity Blood Filter, also called the Seraph 100, which is also labeled as the Onco-Seraph 100, also called the ONCObind Seraph 100, is a device as that term is defined in section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h)(1), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. This letter also requests prompt corrective action to address the violations cited and discussed in your written responses dated June 25, 2025, July 25, 2025, and September 15, 2025.The inspection was conducted under the Bioresearch Monitoring (BIMO) Program designed to ensure that data and information contained in requests for IDEs, Premarket Approval applications, and Premarket Notification submissions are scientifically valid and accurate. Another objective of the program is to ensure that human subjects are protected from undue hazard or risk during the course of scientific investigations.Our review of the inspection report prepared by the OBMI revealed serious violations of Title 21, Code of Federal Regulations (CFR) Part 812 - Investigational Device Exemptions, which concern requirements prescribed under section 520(g) of the Act, 21 U.S.C. § 360j(g). A device is adulterated under section 501(i) of the Act, 21 U.S.C. § 351(i), if the device for which an exemption has been granted under section 520(g) of the Act, 21 U.S.C. § 360j(g), for investigational use and the person who was granted such exemption or any investigator who uses such device under such exemption fails to comply with a requirement prescribed by or under such section.At the close of the inspection, the FDA investigator presented an inspectional observations Form FDA-483 for your review and discussed the observations listed on the form with you. The deviations noted on the Form FDA-483, your written responses, and our subsequent review of the inspection report are discussed below:1. Failure to obtain FDA approval prior to implementing a change to the investigational plan [21 CFR 812.35(a)(1)].A sponsor is responsible for obtaining FDA approval prior to implementing a change to the investigational plan except for certain changes described in 21 CFR 812.35(a)(2) through (a)(4). Your firm failed to obtain FDA approval for changes to an investigational plan that required FDA approval prior to implementation and no exception applies to these circumstances. Specifically, review of your “Emergency/Compassionate Use Requests” log indicates that investigational devices, specifically Seraph 100 devices, were shipped to(b)(4), (b)(6)Hospital on April 29, 2024, for Emergency/Compassionate Use (CU).Your firm’s email communications with(b)(4), (b)(6)Hospital dated April 27-28, 2024, indicate that these devices were shipped for treatment of a patient under the CU pathway. However, FDA approval for CU was not obtained prior to the devices being distributed. Furthermore, your firm failed to adhere to work instruction, WI017, “Use of Unapproved Devices in United States,” which states “For Compassionate Use Case, FDA approval is required prior to use of the unapproved device,” and specifies that “If there is an IDE for the device, ExThera Medical (IDE sponsor) needs to submit an IDE supplement requesting approval for a compassionate use under section §812.35(a) to treat the patient.”Additionally, the log indicates that a second Emergency/CU request for(b)(4), (b)(6)Hospital was received on November 5, 2024, for which the “Emergency/Compassionate Use Requests” log indicates “devices on hand.” Review of your firm’s email communications dated November 5-6, 2024, indicates that these devices were approved for emergency use. However, a report was never submitted to FDA documenting the distribution of devices for use in treating the identified patient.Approval of an IDE permits investigational device use only in accordance with the approved investigational plan and within the specific study parameters, investigational sites, and patient populations described in the approved study protocol. Distribution of an investigational device for compassionate use to patients not enrolled in the study constitutes a change to the investigational plan requiring prior FDA approval. Obtaining prior approval for compassionate use is essential to ensuring that the rights, safety, and well-being of patients being treated under compassionate use are adequately protected. Furthermore, distributing investigational devices for compassionate use without prior approval has the potential to introduce additional risks, including inadequate device accountability, which can lead to unapproved uses of the device that further compromise the protective safeguards for patients and threaten public health safety.Your written responses to Form FDA-483 are inadequate. Your June 25, 2025, response provided clarification that in both the April and November 2024 cases, devices that were shipped for compassionate use were not used due to changes in the patient’s circumstances. This response also mentioned corrective actions that you have completed, including initiating updated work instruction WI-00011 (piloted as an update from WI017), “Use of Unapproved Devices in United States,” and providing training to personnel on the updated work instruction. However, your work instruction WI-00011 raises significant concerns as further described below. Your July 25, 2025, and September 15, 2025, responses did not provide additional information regarding this observation.Work instruction WI-00011 incorrectly suggests that your device can be distributed and used in certain states based on your compliance with Federal and state “Right to Try” laws and includes template letters for physicians to request device access that cite the use as being “in accordance with the Federal Right to Try Act of 2017, 21 U.S.C. §§ 360bbb-Oa through 360bbb-Oc.” The Federal Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try); however, is not applicable to devices, and compliance with a state “Right to Try” law that conflicts with applicable Federal law would not relieve your firm of compliance with Federal law. WI-00011 should be corrected to help ensure compliance and prevent inappropriate distribution and use of your device. Additionally, your response to this letter should include information on the disposition of any devices inappropriately distributed in accordance with these procedures and plans to report to the IDE(s) the specific cases (if any) in which these devices were used.Additionally, your responses did not indicate whether the devices authorized for use at(b)(4), (b)(6)Hospital in April and November 2024, were returned or properly disposed of following those cases, which raises concerns that the disposition of these investigational devices was not properly managed. Poor handling of device disposition creates safety and public health risks, as this can lead to unapproved and inappropriate uses of the investigational device. Therefore, your corrective actions should include a plan to conduct a complete accounting of all investigational devices distributed to(b)(4), (b)(6)Hospital and other entities listed on the “Emergency/Compassionate Use Request” log. Please include details of the disposition of these devices in your response to this letter. Furthermore, work instruction WI017 should be revised to include additional instructions on handling of unused or leftover devices.2. Failure to ensure proper monitoring of the investigation and failure to secure clinical investigator’s compliance with investigational plans [21 CFR 812.40, 21 CFR 812.46(a)].A sponsor is responsible for ensuring proper monitoring of an investigation. As part these monitoring responsibilities, a sponsor is responsible for securing its clinical investigator’s compliance with the investigational plan. ExThera failed to properly monitor its clinical investigations and failed to provide evidence for verification and attestation that informed consent was signed for enrolled subjects. Examples include, but are not limited to, the following:During the inspection on May 30, 2025, your firm was asked to provide documentation demonstrating that informed consent was obtained from enrolled subjects for the Purify Study (IDE G210074) and Oscar Study (IDE G230144) and that the required monitoring procedures were conducted. However, your firm was unable to provide evidence of verification and attestation that informed consent was signed for enrolled subjects and that monitoring procedures were followed. Additionally, on June 4, 2025, you signed an affidavit confirming that, “When requested during inspection to provide evidence of informed consent verification, ExThera was unable to provide such evidence.” This indicates that, for both studies, you failed to ensure proper monitoring of the informed consent process, a critical aspect of clinical study conduct, and that you failed to adhere to your clinical monitoring plan which requires verification of informed consent as described below.For IDE G210074 (Purify Study), Clinical Monitoring Plan v2.0 states the following:o Section 2, “Objectives,” states, “Verify that informed consent is obtained prior to study procedures.”o Section 8.3.1, “Review of Informed Consent Forms (ICFs),” states, “If the ICF is not available and cannot be verified, the monitoring visit will be delayed until the ICFs can be reviewed.”For IDE G230144 (Oscar Study), Clinical Monitoring Plan v2.0 states the following:o Section 8.3.1, “Review of Informed Consent Forms,” states, “Verify that ICFs are up-to-date, properly documented, and maintained in accordance with GCP and ethical guidelines.”Proper monitoring helps ensure that the safety, rights, and well-being of study subjects are protected, the study data are complete and accurate, and that the study is conducted in accordance with good clinical practice. Monitoring should be an on-going program performed with the frequency necessary to ensure that the investigation is conducted according to the investigational plan, FDA regulations, and any conditions of approval required by the FDA or the reviewing IRB. Inadequate monitoring of informed consent puts subjects at risk of being enrolled and treated in the study without having given proper informed consent and potentially can lead them to undergo experimental procedures or forego standard of care treatment alternatives without fully understanding the associated risks and likelihood of benefit.Your responses to Form FDA-483 are inadequate. Your June 25, 2025, response indicated that the root cause of this violation was due to informed consent verification and documentation processes outlined in the clinical monitoring plan as well as the clinical monitoring procedures (CP018) not being followed completely, which led to inadequate documentation and inability to provide documents upon request. Additionally, procedure CP018 did not require verification of screening and verification logs against an informed consent form log, and there was no master log of screening and enrollment maintained. This response further indicated that the firm has implemented corrective actions, including verification of all signed informed consent forms and/or monitoring reports included in the trial master file and revision of clinical standard operating procedures (SOPs) and work instruction along with training. Your June 25, 2025, and July 25, 2025, responses also stated a plan to update the clinical monitoring plan for IDE G230144 to reflect the changes made within the updated procedures and submit to the FDA for approval, prior to any new enrollment. However, a copy of the revised document was not provided. A copy of the revised clinical monitoring plan is needed in order for FDA to verify that the proposed changes have been adequately implemented. Your September 15, 2025, response did not provide additional information regarding this observation.Unapproved Device ViolationsIn addition, FDA has determined that the Seraph 100 Microbind Affinity Blood Filter is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the device as described and marketed. The Seraph 100 Microbind Affinity Blood Filter is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81. The device is further misbranded under 502(a) of the Act, 21 U.S.C. § 352(a) because of false and misleading statements about the regulatory status of the device.FDA has reviewed your company’s website at https://extheramedical.com, and various public statements by your firm’s officials as described below. Your firm’s promotion of the device is in violation of FDA’s regulations and the Act. For example, ExThera’s Chief Medical Officer, Lakhmir “Mink” Chawla, M.D., stated that the Seraph 100 device is approved in the US, is safe, and is effective for a range of intended uses:a. In December 2024, Dr. Chawla stated the following in a podcast titled, “Dr. Mink Chawla: Blood Filter Seraph-100 Shows Promise To End Long COVID”:i. “Look we have had people under an IRB… under compassionate use with long COVID get the filter… clinically, their brain fog has improved, their fatigue has improved, and so clinically we’re seeing real benefit.” (56:48)ii. “This device has been in over 2,500 patients now, it’s very safe. It’s as safe as a dialysis procedure. So when you have a nice safety profile, you can move from the sickest patients in the intensive care unit which is what we did for COVID, and now we’re moving into outpatients who have cancer, who have long COVID, chronic viremia, chronic Lyme, etc. … and can we help people to treat the disease of aging.” (1:07:38)This podcast is available to the public at https://open.spotify.com/episode/1Mbq1sL40dB8VIv61lGBzW?si=xGlJSdO0QsiIyHqKmB7Kkw%0A&nd=1&dlsi=dd2604be25b141ee.b. In September 2024, Dr. Chawla stated at an Abundance360 Longevity Platinum conference in San Diego that the device is safe and that it is effective at removing a broad range of pathogens, is effective for COVID treatment, and is “… approved in the US for COVID-19,” despite a lack of FDA approval for any indication. A recording of this presentation is captioned with the statement, “This video introduces the ExThera Filter1which Lumati is offering as part of its unique HemoDetox protocol,” and is available to the public at https://vimeo.com/1014979373?share=copy#t=0.c. In November 2024, Dr. Chawla stated in a promotional video of HemoDetox treatments that the device is effective at removing pathogens and has shown clinical benefit in the treatment of long COVID. This video is available to the public at https://vimeo.com/1031732539?autoplay=1&muted=1&stream_id=Y2xpcHN8MjIwMDU1MzgyfGlkOmRlc2N8W10%3D.Your firm’s promotion represents the Seraph 100 as being approved in the United States. However, the Seraph 100 does not have an approved PMA. Your firm’s promotion provides evidence that the device is intended for uses for which you have been advised you would require an approved PMA as well as other uses not previously discussed with FDA, including, but not limited to, the treatment of COVID-19, long COVID, cancer, chronic viremia and Lyme disease.FDA has corresponded with ExThera regarding ongoing concern about ExThera’s marketing of the Seraph 100. Specifically, during the interactive review of IDE supplement G230144/S002 (email dated July 26, 2024) FDA requested that ExThera remove promotional claims and claims of safety and effectiveness from the company’s labeling and from its public webpage because those claims appeared to violate the IDE labeling regulations for investigational devices as detailed in 21 CFR 812.5(b) and 21 CFR 812.7.FDA issued an It Has Come to Our Attention (IHCTOA) Letter to ExThera on July 17, 2024, notifying them that Quadrant Clinical Care (Quadrant) was promoting the Seraph 100 device and that Quadrant’s public webpage stated that the device was FDA cleared to treat COVID-19 and sepsis. FDA also notified ExThera in that IHCTOA letter that, as the U.S. device manufacturer for the Seraph 100 Microbind Affinity Blood Filter, ExThera should ensure that distributors outside the U.S. do not falsely claim that their device has FDA clearance or approval. We note that the Quadrant Clinical Care website is currently unavailable.ExThera’s July 25, 2024, response to the IHCTOA letter acknowledged the following:“We understand the importance of accurate representations about the regulatory status of the Seraph in the United States, and we also acknowledge the Company’s responsibility to ensure that its foreign distributors do not misrepresent or overstate the device’s regulatory status… The Company takes this issue very seriously and has taken additional precautionary measures out of an abundance of caution following receipt of your letter, as described herein.”“Your letter accurately describes the regulatory status of the Seraph device, which is not currently approved or cleared by FDA for any indication.”“In closing, ExThera affirms its commitment to ensuring that marketing materials posted by its distributors accurately describe the regulatory status of the Company’s products in the United States.”However, your firm’s website and other current public statements are inconsistent with your commitments in your response to the IHCTOA letter and made during the review of your IDE submissions.For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Our office requests that ExThera cease any activities that result in the misbranding or adulteration of the Seraph100 Microbind Affinity Blood Filter, such as the commercial distribution of the device for the uses discussed above.In addition to the above violations found during the inspection, it was observed on May 29, 2025, that your website’s Frequently Asked Questions (FAQ) webpage included a section titled “Are there any known side effects or potential dangers?” under which your firm claimed: “The Seraph 100 safety profile is consistent with standard extracorporeal labeling.” The Seraph 100 Microbind Affinity Blood Filter is not approved for marketing in the United States, meaning that a determination of safety or effectiveness has not been completed, and as such the safety profile including the risks of the device are undetermined for U.S. patients. The statement on your webpage implied that the safety profile of the device had been established and that the risks of the device had been found to be consistent with those of approved devices. This could have misled readers into believing that the device had been proven to be as safe as approved extracorporeal devices.You acknowledged the observation and revised your webpage as well as took additional corrective and preventative actions, including conducting a review of all advertising, promotional, and website materials. However, your corrective and preventative actions did not include plans for ensuring that promotional materials that are made available by your distributors do not make inappropriate claims of safety and effectiveness, including how you plan to communicate to your distributors to remind them that your device has not been approved and is subject to regulations prohibiting the promotion of an investigational device, and therefore, should not be represented as safe and effective.The violations described above are not intended to be an all-inclusive list of problems that may exist with your clinical studies. It is your responsibility as a study sponsor to ensure compliance with the Act and applicable regulations.Within 15 working days of receiving this letter, please provide documentation of the additional corrective and preventative actions that you have taken or will take to correct these violations and to prevent the recurrence of similar violations in current or future studies for which you are the study sponsor. Any submitted corrective action plan must include projected completion dates for each action to be accomplished as well as a plan for monitoring the effectiveness of your corrective actions. Failure to respond to this letter and take appropriate corrective action could result in the FDA taking regulatory action without further notice to you.Your response should reference “CMS# 715068” and be sent via email to: Irfan.Khan@fda.hhs.gov.A copy of this letter has been sent to FDA’s OII OBMI Division 4 via email at OIIBIMODivision4Correspondence@fda.hhs.gov. Please send a copy of your response to that office.The Division of Clinical Policy and Quality has developed introductory training modules in FDA-regulated device clinical research practices, which are available on the FDA website. The modules are for persons involved in FDA-regulated device clinical research activities. These modules are located at the following website address: http://www.fda.gov/Training/CDRHLearn/.If you have any questions, please contact Melanie Daniels by phone at (301) 837-4289 or email at Melanie.Daniels@fda.hhs.gov.Sincerely,/S/Ouided Rouabhi, MSActing DirectorDivision of Clinical Policy and QualityOffice of Clinical Evidence & AnalysisOffice of Product Evaluation and QualityCenter for Devices and Radiological Health/S/Michael J. HoffmannDirectorOffice of Health Technology 3Gastrorenal, ObGyn, General Hospital,and Urology DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological Health____________1FDA is only aware of one device from ExThera, the Seraph 100 Microbind Affinity Blood Filter, also called the Seraph 100, which is also labeled as the Onco-Seraph 100, also called the ONCObind Procedure.

WARNING LETTERBeta Bionics, Inc.MARCS-CMS 717927 —January 28, 2026Product:Medical DevicesRecipient:Sean SaintChief Executive OfficerBeta Bionics, Inc.11 HughesIrvine,CA92618United States(b)(6)@betabionics.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #717927January 28, 2026Dear Mr. Saint:During an inspection of your firm located in Irvine, CA from June 9, 2025, through June 26, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the iLet Dosing Decision Software and the iLet ACE Pump, which are part of the iLet Bionic Pancreas System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality System Regulation ViolationsThis inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21,Code of Federal Regulations(CFR), Part 820.We received responses from Neal Grant, Director, Quality Systems dated July 18, 2025, August 29, 2025, and October 29, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to adequately establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example:A. Your firm failed to adequately analyze quality data, such as complaints, to identify existing and potential causes of nonconforming product or other quality problems and utilize appropriate statistical methodology to detect recurring quality problems. For example:i. Your firm failed to implement corrective and preventive actions (CAPA) for complaints related to device malfunctions that led to serious adverse health outcomes, as required by Section 6.1.3 (Section 1.4 of Revs G and H) of your firm's corrective and preventive action procedure, Corrective and Preventive Actions, SOP05, Rev I, Section 6.1 (Section 6.6 of Rev I) of the firm's complaint handling procedure, Product Complaints, SOP13, Rev H, and Section 9 (Section 6.9 Rev I) of the firm's complaint handling procedure, Product Complaints, SOP13, Rev H.a. Investigators observed(b)(4)complaints reporting Faulty Motors, including one reporting the patient suffered Diabetic Ketoacidosis, confirmed by your firm to be device malfunctions, where you took no corrective actions and provided no justification for inaction, despite identified safety risks.b. Investigators observed(b)(4)complaints reporting hypoglycemic episodes that were attributed to Use Error – Unintended Insulin Delivery associated with the patients’ incorrectly changing the insulin cartridges. 107 complaints were submitted to the FDA as serious injury Medical Device Reports for severe hypoglycemia or intervention required to prevent severe hypoglycemia. Your firm's User-Related Risk Analysis, RA000021, identified that use errors with the iLet Bionic Pancreas System could trigger unintended insulin doses potentially large enough to cause death (classified as the highest risk level, Severity(b)(4)). Despite this identified safety risk, your firm closed 56 related complaints without implementing corrective actions to address the identified use errors or documenting justification for why corrective actions were deemed unnecessary.ii. Your firm conducts complaint trending through your risk management procedure, Risk Management Review, SOP 14.1, Rev B, Release Date 2023-03-13, to determine if escalation to corrective and preventive action (CAPA) is warranted. Your firm’s complaint trending process is inadequate, in that:a. Inconsistencies were observed between what your firm claims to analyze versus what is documented in your trending analysis. For example:1. Your firm’s complaint trending provided uses “As Reported Complaint Code: Term” and the part of the system (e.g., iLet device, luer connector, cartridge, etc.), but it does not trend complaints by “Complaint Conclusion” unless there was an associated MDR. Your firm’s Vice President of Quality Assurance stated that they also look at complaint conclusions on everything (with the exception of “not our product”) but that it was just not in the presentation.2. Multiple codes with identical or nearly identical meanings were found (e.g., "Use Error – User Did Not Announce Meals" vs. "User Error – Did Not Announce Meals"). Similar codes could dilute trending data for specific complaint types like meal announcements.b. Your firm uses multiple trending rates for complaint analysis that could lead to underestimation of meal announcement complaint rates, potentially affecting safety signals and risk assessment accuracy. For example: Your firm’s complaint trending uses trending rates, such as quantity of complaints per month and as a percentage of the total iLet shipments within a given time period. Your firm’s Vice President of Quality Assurance explained that they also use rates per opportunity. For example, users have approximately ten (10) opportunities to change their cartridge per month, so your firm will trend the percentage by(b)(4). A second example is that users have approximately 90 opportunities to meal announce (three times a day over 30 days), so your firm will trend the same as previous except(b)(4). Your trending rate for meal announcements (90 per month) is not representative of all users’ eating habits and as such might be affecting the rate at which your firm is trending meal announcement related complaints. In addition, your firm’s instructions state that “If you eat a very low carb diet or no carbs at all, you should not announce meals.”B. Your firm's verification of effectiveness (VOE) for CAPA 0050 is inadequate, in that, it tested(b)(4)employees on updated training materials, rather than actual iLet users, which was not representative of user population base (e.g. people 6 years of age or older with diabetes mellitus). Additionally, your CAPA 0050 does not address the allegations of hypoglycemia during the adaptation phase of initial use of the iLet.Your firm opened CAPA 0050 to investigate hypoglycemia allegations during the iLet Bionic Pancreas System's initial adaptation phase. Your firm determined that the root cause was users' inadequate understanding of diabetes management while using the device, leading to maladaptive behaviors and misuses. Your firm documented the related misuses in RA000021, Rev. E, User-Related Risk Analysis. Your firm initiated preventive actions for CAPA 0050, to include: 1) Holding office hours for health care providers; 2) Improving user training materials; 3) Creating information materials for users transitions from hybrid closed-loop systems and for users new to pump therapy; and 4) Improving guidance materials for health care providers.Additionally, Section 2.8.3 of your firm's corrective and preventive action procedure, Corrective and Preventive Actions, SOP05, Rev H, Release Date 2024-01-09, and section 1.1 of your firm’s work instruction, CAPA Process, WI000053, Rev C, Release Date 2024-01-09, state that an independent investigator and not the CAPA owner is responsible for executing the verification of effectiveness plan and documenting such activity. However, your firm’s CAPA owner also completed the verification of effectiveness activities for CAPA 0050.C. Your firm’s procedure, Corrective and Preventive Actions, SOP05, Revs G – I, states that CAPA requests are warranted for systemic issues that affect the quality of products or services, especially if: an incident caused injury or death; there are multiple occurrences of the same event, typically three within a rolling(b)(4)period; or a risk assessment identifies the issue as critical. Your firm failed to maintain records to demonstrate that the cause of nonconformities was investigated; the appropriate action(s) needed to correct and prevent recurrence of nonconforming product were identified; actions taken were verified or validated to ensure the actions were effective and did not adversely affect the products; changes in methods and procedures were implemented; and that information related to the nonconforming products was disseminated to those directly responsible for assuring the quality of the products or prevention of such products.Specifically, investigators observed 15 complaints (dated from July 2023 – December 2023) reporting damaged pump displays, where your firm's product evaluation confirmed the screens were bowed or delaminated. Per your firm’s System Risk Analysis, iLet Bionic Pancreas System, DeLorean (Insulin), RA000005, the risk to patients from being unable to read the display can result in hyper or hypoglycemia and is assigned a Severity of(b)(4)(Life-threatening serious injury that requires emergency professional medical intervention). Your firm implemented design changes to address these nonconformities (adding Vent to housing to vent internal volume of iLet to ambient pressure, per QP000171); however, no records were maintained to document any corrective actions or reference to CAPA records.D. Your firm failed to adequately document its investigation into device failures due to 5-minute delayed glucose readings instead of real-time data. Your associated Health Hazard Analysis, HHA-2024-002, dated 04/12/2024, states that this issue could potentially lead to the basal and/or correction controller not increasing insulin dosing for high or upward trending Continued Glucose Monitoring (CGM) values or the basal controller not reducing or suspending insulin based on downward trending CGM values. Reportedly, this issue was investigated in collaboration with your CGM supplier, resulting in your firm implementing a temporary software change on 04/05/2024 to mitigate patient risks, while your supplier implemented a permanent solution, however, your firm failed to document this investigation.We reviewed your firm’s responses dated July 18, 2025, August 29, 2025, and October 29, 2025, and conclude that they are not adequate. Your firm's assessment conducted in CAPA 0061 - CAPA VoE Review states, in relation to CAPA-0050, that the Verification of Effectiveness (VoE) was appropriate because it directly measured users' understanding after updated training, addressing the identified root cause, user knowledge gaps. The 100% pass rate on the assessment demonstrates that the revised training effectively improved comprehension related to safe iLet use. However, your firm also indicated in your response that you updated your VoE plan for CAPA-0050 and established a new plan to evaluate CGM-measured percent median time below 54 mg/dL in the user population before and after corrective measures implementation. Your success criteria was established as a(b)(4)% or greater reduction in percent median time below 54 mg/dL, which you state would indicate effectiveness of the corrective measures. Supporting evidence of new CAPA-0050 Verification of Effectiveness (VoE) plan was not provided. The root cause determination and verification of effectiveness criteria for CAPA-0050 is deficient in that it fails to distinguish between system design issues versus user training deficiencies and subsequently the preventive actions were solely focused on training improvements without addressing potential device design issues. It is not clear if an evaluation was made of whether the iLet's design of device (e.g. user interface, alert systems, or other potential design issues) could have contributed to maladaptive behaviors.2. Failure to adequately establish and maintain procedures for validating the device design to include an adequate risk analysis, as required by 21 CFR 820.30(g). For example:Your firm’s risk management procedure, Risk Management Review, SOP 14.1, Rev B, Release Date: 2023-03-13 states in Sections 1.2 – 1.3 that the Head of QA has overall responsibility for collecting and reporting post market feedback information to management to determine if the product is performing within the risk profile as determined by the products risk management documentation. The following sources provide information that is assessed against the associated risk management documentation: Management Review, Design Testing (non-clinical), Regulatory affairs information pertinent to the bionic pancreas, Nonconforming Material Reports (NCMRs), Manufacturing Data (e.g., yields), Complaints, Health Hazard Assessments, Competitor Information, Published Literature, Customer Feedback including surveys, Clinical Investigations and Follow up. The review of design, production and post market surveillance data and its assessment against the risk profiles per the related risk management documentation shall occur(b)(4), at a minimum.Your firm's System Risk Analysis, RA000005, for your iLet Bionic Pancreas, failed to include post-market risks identified through your firm’s complaint data, as required by your procedure. Specifically,A. Your firm has failed to incorporate known post-market safety data into your risk management processes.i. Investigators observed(b)(4)complaints, dated October 2024 – June 2025, reporting various malfunctions of the iLet Bionic Pancreas Model TA000036 caused by failure of the devices’ printed circuit board assembly manufactured by a supplier. Your firm’s risk analysis does not assess, or control identified hardware hazards.ii. Investigators observed two complaints, received on 02/07/2024, and 01/01/2025, reporting over infusion of insulin resulting in severe hypoglycemia or hypoglycemia requiring medical intervention where the users reported involuntary meal announcements. Your firm’s risk analysis fails to assess hypoglycemia risk from involuntary meal announcements.B. Your firm’s risk management procedure, Risk Management Review, SOP 14.1, Rev B, Release Date: 2023-03-13 states in Section 4 – Unanticipated Risks that as a result of the risk management assessment per this SOP, any unanticipated events are assessed based upon the severity and occurrence of the associated harm and hazard. This assessment includes a review of prior Design Verification Testing (DVT) and/or Process Validation activities to verify potential, applicable risk mitigations previously established. Rationale for non-escalation shall be documented in the RMRR and approved by the Head of Quality.Your firm has identified a hazard; however, the risk control implementation and validation are absent in your firm’s risk analysis. Specifically,Complaint # COM-0000000790 was reviewed reporting a patient with dementia gave themselves multiple successive meal boluses, although they were not eating. The following morning the patient’s blood glucose was 40 mg/dl. The caregiver attempted to wake the patient, but the patient was unresponsive. While your firm’s System Risk Analysis identifies that vulnerable populations (patients with diminished capacity), might be making inappropriate therapy decisions, resulting in hyper or hypo glycemia, your risk analysis fails to: 1) Document any risk control measures to address this specific hazard; 2) Demonstrate calculation of post-mitigation risks; 3) Show how the identified risk is being adequately controlled.C. Despite approximately 529 complaints reporting insulin cartridges or cartridge connectors leaking while in use, your firm's System Risk Analysis, RA000005, for the iLet Bionic Pancreas does not evaluate the risk to patients from cartridges and cartridge connectors leaking during use.We reviewed your firm’s responses dated July 18, 2025, August 29, 2025, and October 29, 2025, and conclude that they are not adequate. Your firm’s response states that you plan to update your risk management procedures; however, it does not address whether and how data sources from your firm’s quality system, such as complaints, CAPAs, nonconforming product, etc., will interface with your firm’s risk analysis process to determine if further corrective actions or regulatory decisions are required.3. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).A. Your firm failed to adequately investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications. For example:i. Investigators review of complaint data from June 2023 – June 2025 found over 500 complaints reporting iLet Bionic Pancreas system insulin cartridges or cartridge connectors leaking. The System Risk Analysis, iLet Bionic Pancreas System, DeLorean (Insulin), RA000005, does not identify the risk to patient from cartridge/connector leaks leading to under delivery of insulin to patients; however, the Risk Analysis identifies the risk of system under-delivery of drug resulting in hyper or hypo glycemia due to administration sets leaking as Critical - Results in permanent impairment of life-threatening injury.Your firm did not adequately address 31 complaints relating to cartridge or connector leaking. Specifically, your firm closed these complaints without investigation, concluding that no product deficiencies or defects were indicated, and that the complaints did not warrant an investigation. Additionally, by not investigating these product failures, your firm failed to recognize safety risks that could cause adverse events. For example, 18 of the 31 complaints (e.g., COM-0000007869, COM-0000007398, and COM-0000007157) reported that patients experienced hyperglycemic health effects.ii. Investigators observed that your firm failed to adequately investigate 21 complaints involving bent cannulas or infusion set failures associated with reports of diabetic ketoacidosis (DKA). Your iLet Bionic Pancreas System is distributed to customers with Convatec Inset and Contact Detach infusion sets manufactured for you by your infusion set supplier. Your firm is responsible for intake of complaints for the infusion sets and forwarding them to Convatec. Review of your complaint data shows that approximately 33% of the complaints in your complaint database are related to failure of the infusion sets, with the top failures reported as bent cannula, adhesive issues, and infusion set failures, and with 99.7% of the affected sets not returned by the customers. However, your firm did not request the sets to be returned for further investigation by your infusion set supplier.B. Your firm failed to implement and maintain adequate complaint files, per your procedures.Specifically, investigators observed that your firm had not adequately implemented your complaint handling procedure, Product Complaints, SOP13, Rev H, Release Date 2023-01-28, which requires review of all reported product experiences within(b)(4)to determine if they constitute a complaint.(b)(4)is the electronic quality management system, used by your firm. Your firm’s work instruction, WI000085, provides instructions for completing the product complaint process. Section 6 of work instruction WI000085, Revs A-C, state that if a complaint was created via(b)(4)(e.g., Case), various fields such as Event as Reported, Event Date, Aware Date, etc. will be auto filled into(b)(4). It also describes how new complaints can be directly entered into(b)(4).For example, your firm did not adequately address a user reported hyperglycemic event,(b)(4)Case 00015304, involving your iLet device. Specifically, on June 3, 2024, a user reported hyperglycemic event requiring emergency room treatment and insulin administration. On June 5, 2024, the user provided additional details including blood glucose reached 476 mg/dl, stayed high for over 4 hours, and patient developed diabetic ketoacidosis (DKA). On June 5, 2024, your firm closed the case without proper evaluation to determine if it required escalating to a product complaint or if it required reporting. Your firm’s Vice President of Quality Assurance confirmed this was a complaint on June 11, 2025.The adequacy of your firm’s responses cannot be determined at this time, as corrective actions are ongoing. Your firm has committed to implementing a new complaint handling system by October 29, 2025. Corrective actions, such as a retrospective review of complaints, are ongoing, and your firm did not provide complete evidence of implementation of your new complaint handling system. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy. Please continue to send updates regarding the implementation of your corrective actions.4. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21CFR 820.90(a). For example:Your firm failed to adequately control product that does not conform to specified requirements. Firm's procedure for controlling nonconforming product is SOP09, Nonconformance Reporting.Nonconformance Report NCR #191 was opened after 61 out of(b)(4)iLet Bionic Pancreas printed circuit board assembly (PCBA) Mainboards failed testing due to faulty(b)(4)connections. Your firm claimed to have investigated with their supplier, your Vice President of Quality Assurance acknowledged that this investigation was not documented, and no corrective action was taken from the supplier, because this was considered a first-time issue. Your firm later received 19 customer complaints related to iLet Bionic Pancreas Model TA000036 failures caused by defective PCBA Mainboards with improperly installed components.We reviewed your firm’s responses dated July 18, 2025, August 29, 2025, and October 29, 2025, and conclude that they are not adequate. Your firm’s CAPA 0064 NCR/SCAR Review table shows instances where your firm has decided no SCAR is to be opened. The justifications for the following instances are inadequate:Components no longer active (i.e. Component is no longer active in current iLet (TA000048) configuration). It is not clear if these non-conformances still being tracked and adequately investigated. Your response does not address if there are devices in the field that still contain this component or if the supplier still provides components that are active. There are repeated instances in table where the same supplier has sent mixed lots of components, manufactured to incorrect part number or sent mislabeled components, but no SCARs were issued.Component manufactured to incorrect Part Number or Revision (i.e. the components were found manufactured to the incorrect part number. […] No SCAR will be issued as the parts were manufactured using equivalent materials. […] No additional NCRs were issued for a similar incident.)Damage during transportation (i.e. Damage to external shippers). It is not clear if these non-conformances still being tracked and adequately investigated.Typographical errors (i.e. Expiration Date on CoC was incorrect. […] The incorrect expiration on the CoC was a typographical error. The CoC was updated to the correct expiration date that was stated on the product.)Medical Device Reporting (MDR) ViolationsOur inspection also revealed that your firm’s iLet Dosing Decision Software and the iLet ACE Pump are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i. 21 CFR Part 803 - Medical Device Reporting was promulgated under section 519 of the Act, among other provisions. Significant violations include, but are not limited to, the following:1. Failure to report to the FDA the information required by 21 CFR 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). Manufacturers should submit a separate report for each device that it markets that may have caused or contributed to a death or serious injury. For example,A. The information included for Complaint COM-0000008592 describes an event in which a patient experienced hyperglycemia and chest pains while using your firm’s iLet Dosing Decision Software and was subsequently treated with IV fluids and Insulin. The IV fluids rehydrated the patient and corrected electrolyte imbalances, while IV insulin provided a way to lower the high blood sugar (hyperglycemia). If left untreated, chronic hyperglycemia can lead to diabetes complications, such as cardiovascular disease, nerve damage, eye disease and kidney damage. Based on the information included for the complaint and the medical intervention given to the patient, we determined that your firm’s device may have caused or contributed to a serious injury as defined by 21 CFR 803.3(w)(3). The medical intervention was necessary to preclude permanent impairment of a body function or permanent damage to a body structure. Therefore, this event meets the definition of a MDR reportable event under 21 CFR 803.3(o)(2)(i) because the serious injury was or may have been attributed to the iLet Dosing Decision Software, or the iLet Dosing Decision Software was or may have been a factor in a serious injury. Your firm became aware of the event on August 19, 2024, when you acquired the information in this complaint that reasonably suggested a reportable event had occurred. However, no MDR wasB. The information included for Complaints COM-0000025536, COM-0000026475, COM-0000026763, COM-0000003142 and COM-0000005866 describe adverse events in which patients experienced hypoglycemia with blood sugar levels below 70 mg/dL, while using your firm’s iLet Dosing Decision Software, and were treated with glucose drink or candies to raise their blood glucose level. We determined that treatment for hypoglycemia that includes glucose drinks or candies is a medical intervention necessary to preclude permanent impairment of a body function or permanent damage to a body structure because, if left untreated, hypoglycemia can lead to confusion, shakiness, dizziness, and weakness, but if severe and untreated, it can progress to serious complications like seizures, loss of consciousness (fainting), brain damage, coma, and even death. Repeated episodes can also cause reduced cognitive function, cardiovascular issues, and increased risk for future severe lows. Therefore, based on the information included for the complaints involving your firm’s device and the medical intervention given to the patients, we determined that your firm’s device may have caused or contributed to a serious injury as defined by 21 CFR 803.3(w)(3). Each of these events therefore meet the definition of an MDR reportable event under 21 CFR 803.3(o)(2)(i) because the serious injury was or may have been attributed to the iLet Dosing Decision Software, or the iLet Dosing Decision Software was or may have been a factor in a serious injury. Your firm became aware of the information included for Complaint COM-0000025536, which reasonably suggests a reportable event has occurred, on April 23, 2025, and FDA received the corresponding MDR 3019004087-2025-00443 on July 14, 2025, which exceeds the required 30-calendar day timeframe in 21 CFR 803.50(a). Your firm became aware of the information included for Complaint COM-0000026475, which reasonably suggests a reportable event has occurred, on April 30, 2025, and FDA received the corresponding MDR 3019004087-2025-00461 on July 9, 2025, which exceeds the required 30-calendar day timeframe. Your firm became aware of the information corresponding to Complaint COM-0000026763, which reasonably suggests a reportable event has occurred, on May 3, 2025, and FDA received the corresponding MDR 3019004087-2025-00581 on June 10, 2025, which exceeds the required 30-calendar day timeframe. Your firm became aware of the information corresponding to Complaint COM-0000003142, which reasonably suggests a reportable event has occurred, on April 1, 2024, and FDA has not yet received an MDR. Your firm became aware of the information included for Complaint COM-0000005866 on June 20, 2024, however, FDA has not yet received an MDR.2. Failure to report to FDA the information required by 21 CFR 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).For example, the information included for complaints COM-0000004919, COM-0000008065 and COM-0000008452 reasonably suggests that the firm’s iLet ACE Pump malfunctioned (e.g. component failures: memory chips,) while in use, meaning the device failed to meet its performance specifications or otherwise perform as intended under 21 CFR 803.3(k). Specifically, complaint COM-0000004919 describes an “Alert 60 - Bluetooth Communication” error, complaint COM-0000008065 describes a “Touchscreen unresponsive” error, and complaint COM-0000008452 describes a sleep/wake button unresponsive” error. Although the malfunction alerts reference different alert codes, each malfunction is associated with a defective hoverboard. A device malfunction that is associated with a defective hoverboard has previously resulted in a patient sustaining a serious injury. (Refer to complaint COM-0000003142). This prior incident demonstrates that such a malfunction (i.e., one that is associated with a defective hoverboard) is linked to a serious injury. It is reasonable to conclude that a recurrence of these malfunctions that are associated with a defective hoverboard would therefore be likely to cause or contribute to a serious injury. As such, the malfunctions listed in these complaints represent MDR reportable events for which MDRs must be submitted. Your firm became aware of Complaint COM-0000004919 on 5/25/2024, Complaint COM-0000008065 on 8/8/2024 and Complaint COM-0000008065 on 8/8/2024 however, based on our records, FDA has not yet received an MDR for each of the referenced malfunction events.The adequacy of your firm’s response dated July 18, 2025, cannot be determined at this time. In the response, your firm noted it initiated corrective actions to address the reporting issue, including a retrospective review of complaints received since June 2023. However, documentation of these corrective actions was not provided, as they are still ongoing.The adequacy of your firm’s response dated August 28, 2025, cannot be determined at this time. Your firm’s response dated August 28, 2025, is a periodic update and did not include any additional new information.The adequacy of your firm’s response dated October 29, 2025, cannot be determined at this time. Your firm’s response dated October 29, 2025, noted that your firm has a three-phase plan to address the reporting issue. However, documentation of the completion of these corrective actions was not provided, as they are still ongoing.In addition, the inspection revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17(a)(1). For example, during the inspection, your firm presented a document titled “Guidelines for FDA Reporting”, SOP 13.1, Rev. A, dated 2023-10-23, as its MDR procedure. After reviewing the procedure, we conclude that the procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, there are inadequate definitions of what constitutes a reportable event under 21 CFR Part 803. The fact that the procedure does not include a definition from 21 CFR 803.3 for the term “cause or contributed” may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).Your firm’s response dated August 28, 2025, appears to be adequate. In the response, your firm included a copy of its revised MDR procedure titled “Guidelines for FDA Reporting”, Documents Number: SOP 13.1, Rev. B, dated 2025-07-16, along with staff training records. Upon review, the revised procedures have adequately addressed the deficiency described above.Corrections and Removals Violation(s)Our inspection also revealed that your firm’s iLet Dosing Decision Software and the iLet ACE Pump are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i. 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals was promulgated under section 519 of the Act, among other provisions. Significant violations include, but are not limited to, the following:Failure to submit to the FDA within 10 working days of initiating a correction or removal a report required by 21 CFR 806.10. For example:A. Your firm discovered that the iLet Dosing Decision Software had failures regarding glucose values that were 5 minutes old (delayed readings), instead of using new readings as expected. The iLet Dosing Decision Software autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on glucose readings, and it autonomously determines, and commands meal doses of insulin based on meal announcements. Use of the delayed glucose readings resulted in your iLet Dosing Decision Software not performing as intended, not dosing insulin to the patient and patient experiencing elevated blood glucose levels that presents a risk to health. Your firm implemented a software change/release version 1.4.4 to mitigate the risk to health posed by your iLet Dosing Decision Software. The new software version was uploaded to the cloud and made available to the customers for download on 4/5/2024. This action constitutes a medical device correction or removal initiated to reduce a risk to health posed by your device or remedy a violation of the Act caused by your device which may present a risk to health, under 21 CFR 806.10(a). You have not already provided this information as set forth in 21 CFR 806.10(f) (see 21 CFR 806.10(a)(2)), nor was the correction or removal action exempt from the reporting requirements under 21 CFR 806.1(b) (see 21 CFR 806.10(a)(2)). You were therefore required to submit a Report of Correction or Removal to FDA within 10 working days of initiation, under 21 CFR 806.10(b).B. Your firm discovered that the iLet ACE Pump had cybersecurity vulnerability for the Limited Access feature of the iLet Bionic Pancreas System, which is used as a security measure to prevent unwanted access to the pump controls. When either the lockscreen or Limited Access Passcode screen is viewed on the iLet display, other icons are present and active, and(b)(4). This results in unsecured access to change settings, including stopping insulin delivery or giving boluses inappropriately, both of which present a risk to health. Your firm implemented a software fix via DCO #3203 and released Software Version 1.4.3 on 3/26/2024. Beta Bionics sent an email to all customers on 4/1/2024, titled “iLet Software Update”, notifying them that Beta Bionics, Inc. released an iLet Bionic Pancreas Software update. This action constitutes a medical device correction or removal initiated to reduce a risk to health posed by the device or remedy a violation of the Act caused by the device which may present a risk to health, under 21 CFR 806.10(a). You have not already provided this information as set forth in 21 CFR 806.10(f) (see 21 CFR 806.10(a)(2)), nor was the correction or removal action exempt from the reporting requirements under 21 CFR 806.1(b) (see 21 CFR 806.10(a)(2)). You were therefore required to submit a Report of Correction or Removal to FDA within 10 working days of initiation, under 806.10(b).Your firm’s responses to the FDA-483, dated July 18, 2025, August 29, 2025, and October 29, 2025, are not adequate. For the issue related to delayed glucose readings described in paragraph A above, you categorized your action as a device enhancement, stating that the change was to improve a non-violative device’s safety or performance. Even if you categorized the software update as a “device enhancement,” the evidence still indicates that a report of correction or removal was required to have been submitted to FDA because you initiated the correction (i.e., updated the software) in order to reduce a risk to health posed by the device (i.e., inaccurate insulin dosing). The fact that the issue might have also involved a third-party CGM does not change the fact that you initiated the correction to reduce a risk to health posed by your device. Furthermore, there is no evidence that you designed and tested the iLet device to function with the particular CGM at issue.For the issue related to the cybersecurity vulnerability for the Limited Access feature described in paragraph B above, your firm alleges that the issue is non-reportable. We do not agree with this assessment. The evidence indicates that a report of correction or removal was required to have been submitted to FDA because you initiated the correction (i.e., updated the software) in order to reduce a risk to health posed by the device (i.e., prevent unsecured access to the pump controls).In addition, regarding your statement that your firm was conducting a Class III recall, we note that a recall’s classification is assigned by FDA, not the recalling firm (e.g., 21 CFR 7.3(m) and 7.41(b)), and that conducting a voluntary recall does not exempt a firm from the requirement to submit a report of correction or removal under Part 806 (e.g., 21 CFR 806.10(a)(2)). As explained above, you were required to submit a report of correction or removal to FDA.You have not submitted Reports of Correction or Removal to FDA as of 01/15/2026 for either of the failures listed above.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which should address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 717927” when replying. If you have any questions about the contents of this letter, please contact: Shaquenta Perkins at shaquenta.perkins@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or concerning your firm’s devices. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara C. MarsdenActing DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

根据《中华人民共和国行政许可法》第七十条、《药品生产监督管理办法》第二十条的规定，安徽省药品监督管理局依法注销安徽黄太中药饮片科技有限公司《药品生产许可证》（详细信息见附件）。特此公告。附件：注销《药品生产许可证》清单安徽省药品监督管理局                              2026年2月13日附件注销《药品生产许可证》清单企业名称许可证编号注册地址生产地址和生产范围备注安徽黄太中药饮片科技有限公司皖20160284安徽省亳州市高新区亳菊路898号安徽省亳州市南部新区工业区（老子路南侧）：中药饮片（含毒性饮片）***企业申请注销

广东省药品监督管理局通 告2026年 第18号　　经监督检查，深圳市广安利健康药房有限公司等2家药品经营企业的综合评定结论为不符合要求，存在药品质量安全隐患。根据《中华人民共和国药品管理法》第九十九条及《药品检查管理办法（试行）》第六十一条规定，广东省药品监督管理局对深圳市广安利健康药房有限公司等2家药品经营企业采取暂停销售（配送）风险控制措施，现予以公布。序号企业名称药品经营许可证编号综合评定结论风险控制措施1深圳市广安利健康药房有限公司粤BA755000621不符合要求暂停销售（配送）2广州壹邦药业连锁有限公司粤BA020000612不符合要求暂停销售（配送）　　企业应当严格落实主体责任，按照检查处理结果要求暂停销售（配送），排除质量安全隐患后，向广东省药品监督管理局提交整改报告，经复查符合条件后予以解除风险控制措施。　　特此通告。广东省药品监督管理局2026年2月14日

广东省药品监督管理局通 告2026年 第19号　　根据《中华人民共和国药品管理法》第九十九条及《药品检查管理办法（试行）》第六十一条、第六十三条规定，广东省药品监督管理局组织对京誉堂（广东）大药房有限公司现场检查确认，上述企业已完成缺陷项目整改，现决定对该企业解除暂停销售药品风险控制措施。　　特此通告。广东省药品监督管理局2026年2月14日

福建省药品监督管理局行政处罚信息公开表行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业社会信用代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期闽药监厦稽办处罚〔2026〕2号厦门传福堂药业有限公司未按照经注册的产品技术要求组织生产医疗器械远红外治疗贴案厦门传福堂药业有限公司91350200671271135A黄**当事人于2024年10月5日开始生产批号24100501、型号规格100×121的远红外治疗贴。至2024年10月9日，共计生产了每盒6贴装的远红外治疗贴700盒、每盒3贴装的远红外治疗贴1280盒，后分别销售给福建省**医药有限公司、***(福建)医药集团有限公司、福建***医药有限公司、厦门**医药有限公司等单位，上述货值金额（即违法所得）共计28584元。上述批次产品经福建省食品药品质量检验研究院初检和安徽省食品药品检验研究院复检，检验项目“药物添加”均检出水杨酸甲酯药物成分。经调查，当事人为了提高产品功效，在涉案批次产品中添加了水杨酸甲酯、单硬脂酸甘油酯和薄荷素油。当事人经注册的闽械注准20172090126产品技术要求《远红外治疗贴》组成成分为远红外陶瓷粉、甘油、羧甲基纤维素钠、卡波姆940、活性炭、无纺布芯袋、医用透气胶带和离型纸，而水杨酸甲酯、单硬脂酸甘油酯、薄荷素油不属于涉案产品产品技术要求规定的组成成分。当事人未按照经注册的产品技术要求组织生产医疗器械远红外治疗贴的违法行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定，依据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》第八十六条第一款第二项、《福建省药品监管行政处罚裁量适用细则》第二十六条第一项的规定，现责令当事人改正上述违法行为，并决定处罚如下：1.没收当事人召回的涉案批次远红外治疗贴175盒（每盒3贴装）；2.没收违法所得28584元；3.罚款457344元。上述罚没款合计485928元整（肆拾捌万伍仟玖佰贰拾捌元整）。当事人应当自收到本行政处罚决定书之日起十五日内，缴纳上述罚没款。当事人根据本局开具的《福建省非税收收入缴款通知书》，自行选择缴款方式。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。福建省药品监督管理局，2026年2月12日。

行政相对人名称四川新世纪医用高分子制品有限公司行政相对人类别法人及非法人组织行政相对人代码（统一社会信用代码）91510000201884076F法定代表人陈姬行政处罚决定书文号川药监处罚〔2025〕10002号违法行为类型未经许可从事第三类医疗器械经营活动违法事实未取得医疗器械经营许可证，销售第三类医疗器械处罚依据《医疗器械监督管理条例》（国务院令第739号）第八十一条第一款第（三）项处罚类别没收违法所得、罚款处罚内容处罚没款8.664万元处罚决定日期2026年2月11日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:26-HFD-45-02-02Product:DrugsRecipient:Bertrand P. Cole, D.O.Bertrand P. Cole, D.O.110 Corporate Drive, Suite 2Portsmouth,NH03801United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 26-HFD-45-02-02Dear Dr. Cole:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between May 12 and May 16, 2025. The investigator representing FDA reviewed your conduct of the following clinical investigations:Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4)Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4), a wholly owned subsidiary of(b)(4)This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, the FDA investigator presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your June 3, 2025, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated June 3, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312) governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol(b)(4)required the randomization of subjects to receive one of three weekly doses (1.5 mg, 4.5 mg, or 9.0 mg) of the investigational drug(b)(4)or the matching placebo. Subjects in the 4.5 mg and 9.0 mg treatment arms were subdivided into two different titration arms (a and b), with different titration regimens beginning at 1.5 mg and increasing to the target randomized dose.You failed to adhere to this requirement for four out of four enrolled subjects over multiple study visits. Specifically:a. Subject(b)(6)was randomized on November 12, 2024, and was assigned to Arm 3a of the titration regimen, with a maximum weekly target dose of 9.0 mg of the investigational drug. However, this subject was administered 10 mg of study drug on November 12, 2024, and weekly from Visit 6 (Day 22) to Visit 10 (Day 50), receiving a total of 6 incorrect doses of the investigational drug.b. Subject(b)(6)was randomized on November 19, 2024, and was assigned to Arm 2a of the titration regimen, with a maximum weekly target dose of 4.5 mg of the investigational drug. However, this subject was administered 10 mg of study drug on November 19, 2024, and weekly from Visit 5 (Day 15) to Visit 13 (Day 71), receiving a total of 10 incorrect doses of the investigational drug.c. Subject(b)(6)was randomized on November 20, 2024, and was assigned to Arm 1 of the titration regimen, with a maximum weekly target dose of 1.5 mg of the investigational drug. However, this subject was administered 10 mg of study drug on November 20, 2024, weekly from Visit 5 (Day 15) to Visit 8 (Day 36), and weekly from Visit 10 (Day 50) to Visit 13 (Day 71), receiving a total of 9 incorrect doses of the investigational drug.d. Subject(b)(6)was randomized on November 21, 2024, and was assigned to Arm 2b of the titration regimen, with a maximum weekly target dose of 4.5 mg of the investigational drug. However, this subject was administered 10 mg of study drug on November 21, 2024, and weekly from Visit 5 (Day 15) to Visit 12 (Day 64), receiving a total of 9 incorrect doses of the investigational drug.During the time frame that subjects were administered the incorrect doses of the investigational drug, all four randomized subjects experienced multiple adverse events, including nausea, vomiting, stomach pain, fatigue, dizziness, pyrosis (heartburn), and injection-site reactions.In your June 3, 2025, written response to the Form FDA 483, you stated that the site staff administering the investigational product erroneously believed that the vials were pre-dosed, and that the site staff did not adhere to the pharmacy manual instructions. You also stated that the site staff who administered the investigational product for the applicable visits were not originally delegated and trained for study-drug administration.In addition, you detailed the following corrective and preventive actions that your site has taken or plans to take, including: (1) review of the investigational product’s handling and administration procedures with the investigator; (2) site-staff training on the importance of following all investigational product requirements and guidance; and (3) implementation of a new process requiring two trained and delegated staff members to separately calculate and document the doses on a supplemental source page.While we acknowledge the corrective and preventive actions that your site has taken, your written response is inadequate, because you did not include sufficient details regarding the training or procedures implemented at your site to prevent similar violations in the future. In addition, your written response does not provide sufficient details about how you, as the clinical investigator, will ensure adequate oversight of study procedures (for example, adherence to protocol-specified dosing requirements). Without this information, we are unable to determine whether your corrective actions appear adequate to prevent similar violations in future clinical investigations.We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. Your failure to conduct the clinical study in accordance with the protocol resulted in the overdosing of the investigational drug for four out of four enrolled subjects over multiple study visits. This conduct raises significant concerns about your protection of the study subjects enrolled at your site and raises concerns about the validity and integrity of the data collected at your site. This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to:Brittany L. Garr, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW02/02/2026 01:25:08 PM