Delivery Method:VIA Electronic MailReference #:320-25-107Product:DrugsRecipient:Ms. Ayna BianQuality Dept. ManagerYangzhou Yulou Paper Products Co., Ltd.No.888 Jinbao West RoadBaoying XianYangzhou ShiJiangsu Sheng,225800ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-107September 9, 2025Dear Ms. Bian:Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our February 10, 2025, request, and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Yangzhou Yulou Paper Products Co., Ltd., FEI 3032025702, at No.888 Jinbao West Road, Baoying County, Yangzhou, Jiangsu.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)).Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Your firm also failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to ensure conformance with appropriate standards of identity, strength, quality, and purity. (21 CFR 211.113(b) and 211.160(b))Your firm manufactures OTC drug products, including(b)(4)that are labeled as sterile and indicated for use(b)(4). Based on records and information you provided, you did not demonstrate that your(b)(4)are rendered sterile by an appropriate manufacturing process. Your production records do not indicate that you use aseptic processing or(b)(4)sterilization to render your(b)(4)sterile.Furthermore, you did not provide evidence that you performed sterility testing using a validated method and provided microbiological test results with specification of “total number of bacterial colonies ≤(b)(4)CFU/g.” Sterile products introduced to the U.S. market must meet United States Pharmacopeia (USP) Sterility Tests. Microbiological contamination of products labeled as sterile could pose a serious hazard to patients.In response to this letter, provide:A comprehensive assessment of your manufacturing processes which evaluates how you achieve sterility in your drug products.A list of chemical and microbiological specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug products distributed to the U.S. that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and recalling product.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. (21 CFR 211.84(d)(1))Based on the records and information you provided, you did not demonstrate that you tested the identity of incoming components including(b)(4)used to manufacture your OTC drug products. For example, your February 26, 2025, response states that you do not perform identity testing for your components before use in manufacturing.You also did not provide evidence that the(b)(4)you use to manufacture your drug products meets USP limits for(b)(4). See FDA’s guidance document(b)(4).Without adequate testing, you do not have scientific evidence that your components conform to appropriate specifications prior to use in the manufacture of your drug products.In response to this letter, provide the following for all components used in drug products imported to the United States prior to and after our 704(a)(4) request:A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. We note that identity testing is required for every lot of components regardless of supplier test result validation.3. Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products. (21 CFR 211.166(a))The records and information you provided did not demonstrate that the chemical and microbiological properties of your drug products remain acceptable throughout the labeled expiry period. For example, your February 26, 2025, response states that there was no stability data to support the(b)(4)shelf life for(b)(4)shipped to the United States.Without stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.In response to this letter, provide the following for all drug products imported to the United States:A comprehensive, independent assessment and corrective and preventive action plan to ensure the adequacy of your stability program. Your remediation program should include, but not be limited to:o Stability indicating methods, including both analytical and microbiological testso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valido Detailed definition of the specific attributes to be tested at each station (timepoint)All procedures that describe these and other elements of your remediated stability program.4. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. (21 CFR 211.100(a))Lack of Process ValidationIn your response to our 704(a)(4) request, you stated that no validation activities have been performed for your drug products, including(b)(4).Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance documentProcess Validation: General Principles and Practicesfor general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.Inadequate(b)(4)systemIn your response to our 704(a)(4) request, you stated that you qualified your(b)(4)system in 2024, but you did not provide the summary report to support this statement, as requested. Your responses also suggested that you do not perform routine chemical or microbiological analysis to determine suitability of or monitor the(b)(4)generated for use in drug manufacturing.(b)(4)is an ingredient in your drug products.(b)(4)must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. See FDA’s(b)(4).In response to this letter, provide:A timeline for performing appropriate process performance qualification for each of your marketed drug products. Also include an explanation how you will ensure proper satisfactory process performance qualification studies are performed prior to future distribution of any drug products.Your process performance protocol(s) and written procedures for qualification of equipment and facilities.A(b)(4)system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produce(b)(4)that meets(b)(4)USP monograph specifications and appropriate microbiological limits. Include action/alert limits for total counts and objectionable organisms used for your(b)(4)system.A procedure for your(b)(4)system monitoring that specifies routine chemical and microbiological testing of(b)(4)to ensure its acceptability for use in each batch of drug products produced by your firm. Ensure that the total microbiological count limits for your(b)(4)are appropriately stringent in view of the intended use of each of the products produced by your firm.5. Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures. (21 CFR 211.22(d))The records and information you provided demonstrate that you failed to implement written procedures to establish a quality unit (QU) with the CGMP responsibilities and authority to oversee the manufacture of your OTC drug products. For example, your response indicated there were no QU procedures for change control, customer complaints, annual product review, batch review, batch release or rejection, reprocessing and reworking, returns and salvaging, specifications, deviations, or corrective action and preventive action.Based on FDA’s review of records and information provided in response to our request, your firm’s quality systems are inadequate. Please see FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for helpful information regarding implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsDrug RecallOn(b)(4), FDA held a call with your firm to recommend market action for your sterile(b)(4)based on the sterility concerns. On(b)(4), you agreed to recall all(b)(4)from the U.S. market that are labeled as sterile and within expiry.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on August 26, 2025.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Yangzhou Yulou Paper Products Co., Ltd. at No.888 Jinbao West Road, Baoying County, Yangzhou, Jiangsu, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3032025702 and ATTN: Christopher Keating.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCc: Solomon ChenU.S. AgentEmail: regmed.connect@gmail.com

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Ashok RoyPresidentSeniorLife Technologies, Inc.1400 112th Ave., SE, Ste 100Bellevue,WA98004United Statesash.roy@seniorlife.ioIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #707021August 21, 2025Dear Mr. Roy:During an inspection of your firm located in 1400 112th Ave., Bellevue, WA 98004, FEI #3027535342, from March 24, 2025, through March 26, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures SeniorLife.AI. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device 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.Unapproved Device ViolationOur inspection revealed that your SeniorLife.AI mobile application is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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). The SeniorLife.AI mobile application is also misbranded under section 502(o) of the Act, 21 U.S.C. §352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(1).Specifically, you registered your device under 21 CFR 890.5360 Measuring Exercise Equipment. However, the evidence indicates that SeniorLife.AI is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5360 Measuring Exercise Equipment, and that your device is outside the scope of this regulation. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Your firm is distributing SeniorLife.AI for a different intended use, namely the use of artificial intelligence-based algorithms to screen and “pre-diagnose” mobility and cognitive health conditions. Examples from the SeniorLife Technologies, Inc. website (https://www.seniorlife.ai/) include:“Age Smarter – AI Agents for mobility and cognitive health - built for seniors, their families and care providers.”“…Proven to reduced [sic] Fall [sic] by 58% in a 2-year Japanese study.”Mobility Health Agent – Proactively identifies fall risk, recommends interventions, and continuously tracks patient mobility over time.Cognitive Health Agent – Conducts a 5-minute gaze-based test on an iPad to detect early signs of Alzheimer’s — fast, non-invasive, and scalable.“Results — The server-based AI models analyze these input to assess risks and recommend therapies.”One of your FAQ responses says, “Our AI enabled computer vision software can assist a caregiver to perform these tests that provide a quick pre-diagnosis.”“TUG or Timed-up-Go test is an enhanced gait & balance test. It’s typically used to assess frailty and risk of fall. Traditional measurement is the time taken by an older adult to get up from the chair, walk 10 ft (= 3m), and walk back to the chair. Our AI models can measure as many as 7 different parameters.”“Gait and balance test – This test measures several irregularities in walking, balance and even movements of head of an older adult that can be early predictors of Alzheimer’s.”Use of artificial intelligence-based algorithms to screen and diagnose mobility and cognitive health conditions, including Alzheimer’s, are diagnostic functions that are not the same as measurement of exercises. Performing proprietary analyses of patient data for the screening and diagnosis of specific conditions or disorders represents a new intended use compared to use in rehabilitation or physiotherapy to provide or facilitate exercise rehabilitation and to include exercise measurement capabilities, such as for redevelopment of muscles for restoration of motion and providing accompanying measurement of range of motion. Because there is evidence that SeniorLife.AI is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5360, it does not fall within the scope of that regulation and requires a premarket submission prior to marketing.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/HowtoMarketYourD evice/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 SeniorLife Technologies, Inc. cease any activities that result in the misbranding or adulteration of SeniorLife.AI, such as the commercial distribution of the device for the uses discussed above.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 have not received your firm’s response concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued to your firm on March 26, 2025. These violations include but are not limited to the following:1. Failure to adequately establish procedures for corrective and preventive action, as required by 21 CFR § 820.100(a).For example, your firm has not established procedures for implementing corrective and preventive actions.2. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR § 820.198(a).For example, your firm has not established procedures for handling complaints. The investigator reviewed your complaint files and noted that they were not adequately evaluated to determine if an investigation was needed or whether the complaints should be reported to the FDA under Part 803, Medical Device Reporting, as noted by these examples:a. Your firm filed Complaint(b)(4)on(b)(4)to change the test instructions for your software application to examine based on age, device usage, and disease conditions. It is unclear if a proper investigation was conducted to determine the root cause(s) and if it was evaluated for MDR reporting. This complaint remains open and was unresolved during the inspection.b. Your firm filed Complaint(b)(4)on(b)(4), which was closed on 7/10/23. The complaint is about a camera orientation bug where the camera stays in portrait mode when the app is opened, and the phone is turned horizontally. It is unclear if a proper investigation was conducted to determine the root cause(s) and if it was evaluated for MDR reporting.c. Your firm filed Complaint(b)(4)on(b)(4), which was closed on 7/10/23. The issue is regarding a request to change the application after visiting a customer to demonstrate the software application. There were changes such as analyzing Timed Up and Go (TUG) tests, creating reports, and developing specifications for saving data without being overwritten, raising concerns about the quality, reliability, and performance of the software. It is unclear if a proper investigation was conducted to determine the root cause(s) and if it was evaluated for MDR reporting.These examples show that your firm has not established a procedure for handling complaints which increases the likelihood complaints will not be collected and analyzed in a manner that provides a valid quality data source and identification of potential nonconformances and compromises other activities such as corrective and preventive actions.3. Failure to establish procedures for quality audits, as required by 21 CFR § 820.22.For example, your firm has not established procedures for conducting quality audits and has not performed a quality audit since it was established in 2022, despite engaging in medical device operations.4. Failure to establish procedures for training and identifying training needs, as required by 21 CFR § 820.25(b).For example, your firm has not established training procedures and have not conducted training or kept training records to ensure employees perform their assigned responsibilities.Medical Device Reporting (MDR) ViolationsOur inspection also revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. During the inspection, Mr. Ashok Roy, President, and Ms. Shoko Hoshi, Co-Founder and Product Designer, acknowledged that your firm has not developed a written MDR procedure.A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR Part 803, respecting the device.Labeling ViolationIn addition, your device is further misbranded within the meaning of section 502(a) of the Act, 21 U.S.C. § 352(a), which provides that a product is misbranded when its labeling is false or misleading in any particular, because your product’s website includes false and misleading representations, as described below:Representations on and available through your website create an impression of official approval of the device and other potential endorsement by FDA and are false and misleading. The Apple and Android store app links on your website lead to the digital marketplaces from where purchasers can download the software. The images on those digital storefronts include the FDA logo. Further, the language “FDA Approved” appears in those same places. Your product has not received premarket approval from FDA so that representation is false. Your website also contains a statement “FDA Certified,” which is both false and misleading because FDA has not “certified” your device. The display of the FDA logo near images of and information about the products, as well as statements of FDA approval or certification, are misleading because such information implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products and/or establishments. Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the products have been reviewed and approved by FDA. In addition to those implications, the use of the logo is in violation of FDA’s logo policy, which can be found on our website: https://www.fda.gov/about-fda/website-policies/fda-name-and-logo-policy.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 must 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 Establishment Assessment Team 3 Acting Assistant Director, Jeffrey Wooley, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 707021” when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer, Charles J. Chacko, via email at charles.chacko@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. 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 the violations and take prompt actions to correct the violations and bring the products into compliance.Sincerely,/S/Matthew G. HillebrennerDeputy DirectorOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

Delivery Method:VIA UPSReference #:320-25-108Product:DrugsRecipient:Ms. Rachel RendelFounder/OwnerColumbia Cosmetics Manufacturing Inc.1661 Timothy Dr.San Leandro,CA94577-2311United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-108September 11, 2025Dear Ms. Rendel:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Columbia Cosmetics Manufacturing Inc, FEI 2919184, at 1661 Timothy Dr., San Leandro, CA, from April 7 to 14, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your May 2, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).You manufacture over-the-counter (OTC) sunscreen drug products. Your firm failed to conduct adequate investigations into out-of-specification (OOS) results. For example, an OOS result for bulk batch(b)(4)indicated subpotency for one of the active pharmaceutical ingredients (APIs). The corrective action was to reprocess the drug product by adding additional API. The subsequent finished drug product retesting showed that this batch remained subpotent.Furthermore, this reprocessing was performed without the review and approval of your Quality Unit (QU). Your QU released failing drug product without an investigation regarding the finding of subpotent finished product.You did not thoroughly investigate these unexplained discrepancies or identify failures in a drug product to meet any of its specifications. An investigation into the failure of bulk product was initiated only after drug product was released. This investigation was inadequate in that its conclusion, API “evaporation,” was not scientifically supported. Additionally, this investigation failed to address the improper release of subpotent finished product, implement appropriate corrective action and preventive action (CAPA), and expand the investigation to evaluate the impact on other batches of drug products.In your response, you revise your standard operating procedure (SOP) to require investigation of OOS results by your QU. Your response also attempts to invalidate the OOS of finished drug product. Your response is inadequate. Without adequate scientific justification, you claim the test method associated with the OOS is not suitable. Additionally, you fail to extend your investigation to other batches impacted by this method. Therefore, your investigation fails to identify a sufficiently supported root cause or implement appropriate corrective actions. Moreover, your response does not propose to perform any retrospective impact assessment of previously distributed drug products or to re-evaluate the adequacy of any previously invalidated OOS results. As a manufacturer, you have a responsibility to fully investigate unexplained discrepancies and failures to assess impact to drug product quality.For more information about handling failing, OOS, out-of-trend (OOT), or other unexpected results and documentation of your investigations, see FDA’s guidance document:Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Productionat https://www.fda.gov/media/158416/download.In response to this letter, provide:A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for U.S. products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale, and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include, but not be limited to, addressing the following:o QU oversight of laboratory investigations.o Identification of adverse laboratory control trends.o Resolution of causes of laboratory variation.o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified.o Adequately scoping of each investigation and its CAPA.o Revised OOS investigation procedures with these and other remediations.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final QU decisions, and is fully supported by executive management.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You did not perform adequate identity testing on each shipment of each lot of incoming components (e.g., glycerin) used in the manufacture of your OTC drug products. Additionally, you relied on your suppliers’ certificates of analysis (COAs) without establishing the reliability of each of your suppliers’ analyses at appropriate intervals (e.g., avobenzone).For example, you failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin to determine its appropriate identity.Identity testing for glycerin and certain other high-risk drug components include a limit test in the USP to ensure that the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.In your response, you commit to performing testing for DEG and EG in glycerin and provide test results performed on retained component samples. Your response is inadequate in that it fails to consider other high-risk components used in your drug products, including but not limited to, propylene glycol. In addition, your response does not provide sufficient details on how you will establish the reliability of your component suppliers’ COAs at appropriate intervals.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High Risk Drug Components for Diethylene Glycol and Ethylene Glycolto help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.In response to this letter, provide:A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPAs that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).You failed to adequately validate your manufacturing processes to demonstrate that your processes are reproducible and controlled to consistently yield drug products of uniform character and quality. For example, your OTC drug products, Rejuva Mineral Daily Wear Face Protection Moisture SPF16 and(b)(4), were manufactured without adequate validation of your manufacturing processes, including performance of process qualification studies.In your response, you state that you will perform a retrospective validation of the drug products that you manufactured using an unvalidated process. You also state that you will develop a procedure for prospective validation of reprocessed drug products.Your response is inadequate because you do not commit to ensuring prospective validation studies are completed prior to continued distribution of these drug products, nor do you include a risk assessment for marketed drug products manufactured by unvalidated processes. Moreover, it is unclear from your response how your proposed prospective validation of reprocessing will cover every potential reprocessing situation for all drug products manufactured at your facility.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry,Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate PPQ for each of your marketed drug products. Also include an explanation how you will ensure proper satisfactory PPQ studies are performed prior to future distribution of any drug products.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.Ineffective Quality SystemsSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.Responsibilities as a ContractorDrugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance documentContract Manufacturing Arrangements for Drugs: Quality Agreementsat https://www.fda.gov/media/86193/download.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 2919184 and ATTN: Andrew Haack.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

由于贵州为魅颜科技有限公司生产的批号为F2025051801、F2025051802、F2025051901、F2025051902、F2025052901、F2025052902、F2025052801的医用透明质酸钠修护贴（黑膜）存在外观不符合该产品技术要求的质量缺陷，现该公司对其生产的医用透明质酸钠修护贴（黑膜）（注册号：黔械注准20242140060）开展主动召回工作。召回级别为三级。相关召回情况见附表。附件：医疗器械召回事件报告表贵州省药品监督管理局2025年9月16日

根据牡丹江市市场监督管理局《关于对执业药师张秀春禁止从业处罚的申请》，我局于2025年8月7日，依据《执业药师注册管理办法》第二十四、三十六规定，注销张秀春《执业药师注册证》（注册证编号：231221100341），并作为不良信息记入全国执业药师注册管理信息系统。特此公告。黑龙江省药品监督管理局2025年9月16日

根据西藏康馨药业有限公司主动申请，按照《医疗器械监督管理条例》《医疗器械经营监督管理办法》规定，现将其《医疗器械经营许可证》（藏青药监械经营许20160010号）予以注销，将其《第二类医疗器械经营备案凭证》（藏青药监械经营备20160011号）取消备案。特此公告。西藏自治区药品监督管理局　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　              2025年9月16日

为进一步加强对药品经营企业的监督管理，规范药品经营行为，提升药品质量管理水平，近日，渭南市市场监督管理局对蒲城县、澄城县、高新区等地部分药品经营企业开展了为期一周的飞行检查。本次检查结合药品经营环节“清源”行动和医保基金管理突出问题专项整治工作，严格按照《药品经营和使用质量监督管理办法》《药品经营质量管理规范现场检查指导原则》等标准和要求，以严厉打击出租出借证照、制售假药劣药、非法渠道购进药品、不凭处方销售处方药、未按照规定渠道销售第二类精神药品、网络销售《禁止清单》药品等行为为重点，对药品经营企业的质量管理体系运行状况进行了严格检查，并及时将检查中发现的违法违规线索移交相关部门进行处理。下一步，渭南市市场监管局将认真落实“四个最严”要求，深入开展“清源”行动，坚持问题导向、风险防控，引导推动企业持续提升法律意识、责任意识和质量意识，切实督促企业强化底线思维，落实主体责任，筑牢药品质量安全底线，切实保障人民群众用药安全有效。

在我局组织的医疗机构制剂相关监督检查中，发现甘肃岷海中医药养生有限公司岷县岷海诊所备案品种“十六味杞黄胶囊”（甘药制备字Z20220406000）存在备案资料与配制实际不一致的情况，根据原国家食品药品监管总局《关于对医疗机构应用传统工艺配制中药制剂实施备案管理的公告》（2018年第19号）第十六条有关规定，决定取消该品种备案。特此公告。甘肃省药品监督管理局2025年9月16日 

Delivery Method:Via UPS and EMAILReference #:CBER 25-707745Product:BiologicsRecipient:Park ThomasChief Executive Officer and OwnerNuVida Medical LLC5814 S 25th StPhoenix,AZ85040United Statespark.thomas@nuvidamed.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERSeptember 04, 2025CBER 25-707745Dear Mr. Thomas:The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between February 10, 2025, and February 19, 2025. During the inspection, FDA documented that your company distributes two products derived from human amniotic membrane, Procenta and XCELLERATE; a product consisting of three layers of the placental membrane including amnion (amniotic membrane), chorion (chorionic membrane), and the intermediate layer, completeFT1; and a product derived from human dermal tissue, Coll-E-Derm, for allogeneic use (collectively, “your products”).This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).Based on information and records reviewed by FDA, including your website https://nuvidamed.com/ and the website https://extremitycare.com/ linked to your website for more information about your products (last visited September 2025), your products are 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. For example,Procenta, XCELLERATE, and completeFT are each described on the website https://extremitycare.com, linked to on your https://nuvidamed.com website, as “a placental tissue allograft that may be used as a protective barrier in wound care applications. The natural properties of amniotic tissue provide mechanical protection and growth factors to support the management of acute and chronic wounds.”2Coll-e-Derm is described on the website https://extremitycare.com, linked to on your https://nuvidamed.com website, as “a prehydrated human acellular dermal matrix that retains angiogenin and collagen type IV. Angiogenin and collagen type IV may play a key role in supporting revascularization.”Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).Your Procenta, XCELLERATE, completeFT, and Coll-e-Derm products are also human cells, tissues, or cellular or tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d) and are 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, Nuvida Medical LLC does not qualify for any exception in 21 CFR 1271.15, and your products fail to meet all criteria in 21 CFR 1271.10(a).For example, your Procenta, XCELLERATE, completeFT, and Coll-e-Derm products fail 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)). In the donor, amniotic membrane and placental membrane comprising all three layers (amnion, intermediate layer, and chorion) serve as a selective barrier for the movement of nutrients between the external and in utero environment, protecting the fetus from the surrounding maternal environment, and serving as a covering to enclose the fetus and retain fluid in utero. The labeling, advertising, and other indications of your objective intent demonstrate that Procenta, XCELLERATE, and completeFT are intended to perform functions that are not considered the same basic function or functions in the recipient as in the donor. Rather, your Procenta, XCELLERATE, and completeFT products are intended for certain wound care applications, including by providing growth factors,3that fall outside of the basic function of amniotic membrane and placental membrane comprising all three layers (amnion, intermediate layer, and chorion) in the donor. Therefore, Procenta, XCELLERATE, and completeFT fail to meet the criterion for homologous use (21 CFR 1271.10(a)(2)).With respect to your Coll-e-Derm™ product, skin in the donor serves to provide covering, protecting the body from external force, and serving as a water-resistant barrier to pathogens or other damaging agents in the external environment. The labeling, advertising, and other indications of your objective intent demonstrate that your Coll-e-Derm™ product is intended to perform functions that are not considered the same basic function or functions in the recipient as in the donor. Rather, your Coll-e-Derm™product is intended for use in “supporting revascularization.” Supporting revascularization is not a basic function of dermal tissue in the donor. Supporting revascularization would require biochemical stimulation of a wound healing response in the body via cell signaling, which is not a basic function of dermal tissue in the donor. Therefore, your Coll-e-Derm™ product fails to meet the criterion for homologous use (21 CFR 1271.10(a)(2)).Therefore, these HCT/Ps are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.4See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your products are regulated as drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect 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. Your products are not the subject of an approved BLA.Response to the Form FDA-483We have reviewed your response, dated March 12, 2025, to FDA’s Form FDA-483 in detail. We acknowledge your representation that you have corrected the deficiencies documented on the FDA-483. We also acknowledge that you removed certain claims regarding your products from your website based on discussions with the FDA investigator concerning the intended uses of your products. Your voluntary corrections were not sufficient to correct the violations noted in this letter, because your products continue to be intended for non-homologous uses.ConclusionThis letter addresses certain issues regarding your products and is not intended to be an all-inclusive list of deficiencies that may exist in connection with your products. We advise you to comprehensively review your website and other labeling and marketing materials to ensure that you are lawfully marketing your products in full compliance with the FD&C Act, the PHS Act, and their implementing regulations. 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 products are 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 ResearchCc:(b)(4)Oliver BurckhardtChief Operating Officer and OwnerExtremity Care LLC555 E North LnSte 5000, Bldg DConshohocken, PA 19428Leonard R. DufordPresident and Chief Executive OfficerLucina BioSciences, LLC14707 E 2nd Ave GL150Aurora, CO 80011_______________________________1You also market completeFT as an “collagenous amnion/chorion memrane allograft...derived from placental tissue” and a “full thickness amniotic membrane.”2Your product provides growth factors but it is unclear how growth factors would support wound management (such as covering/protecting the wound or providing a moist wound environment) as opposed to wound healing.3As stated above, it is unclear how the growth factors in your products would support wound management as opposed to wound healing. Wound healing is not a basic function of amniotic membrane or placental membrane comprising all three layers (amnion, intermediate layer, and chorion).4Because your products fail 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).