Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Patrick J. TreacyPresident and CEOOnkos Surgical, Inc.77 E Halsey RdParsippany,NJ07054United Statesptreacy@onkossurgical.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 712573July 21, 2025Dear Mr. Patrick J. Treacy:During an inspection of your firm located in Parsippany, NJ from February 4, 2025 through April 4, 2025, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of the ELEOS Limb Salvage System indicated for use in total hip and knee arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with select conditions. 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 Violation(s)This 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 a response from Len Tokish, Vice President of Quality Assurance and Regulatory Affairs dated May 15, 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 establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, including quality requirements, that must be met by suppliers, contractors, and consultants and define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results, as required by 21 CFR 820.50.Specifically, you failed to adequately implement the “Approved Supplier List” section of your “Supplier, Purchasing and Inspection Controls” procedure (SOP-013; Rev. 0-6; Effective: 4/25/16 - 2/3/25) which requires that you “ensure compliance to ISO 13485” for your Tier 1 suppliers as a “method of control” over approved suppliers. For example, you did not ensure compliance to the process validation requirements (clause 7.5.6) of ISO 13485 (Medical Devices – Quality Management Systems – Requirements for regulatory purposes) for the following three (3) Tier 1 suppliers in that you failed to adequately assess and/or document an assessment of the acceptability of their cleaning validations meant to demonstrate that in-process or final cleaning of your ELEOS Implant Devices and Instruments consistently meet your specifications for cleanliness:a.(b)(4)– Tier(b)(4)Final Cleaner of ELEOS Implant Devicesi. You approved the(b)(4)cleaning validation test report TR-2771D-01 (Rev. 1-2; Approved: 1/24/19 and 9/10/21) from this supplier despite it failing to define the maximum allowable devices per gallon per run, as required by section 9.2 of the corresponding test protocol TP-2771D-01 (Rev. 2; Approved: 9/10/21) which states “***The main cleaning parameters that can impact the efficacy of the cleaning process include ***Quantity of parts((b)(4))***.”Similarly, you approved(b)(4)cleaning validation test report TR-2771E-01 (Rev. 1; Approved: 3/18/19) from this supplier despite it failing to document the maximum allowable quantity of(b)(4)and(b)(4)per run, as required by sections 9.3, 9.4, and 9.5 of the corresponding test protocol TP-2771E-01 (Rev. 1; Approved: 8/28/18) which state “***To validate the cleaning process, parts shall be cleaned using(b)(4)over(b)(4)runs***To create a(b)(4)batch of product***Clean what is expected to be a“(b)(4)” load in(b)(4)***A cleaning process should not alter the appearance of parts or cause damage. If applicable, appropriate fixtures to hold the components during cleaning should be included in the study and used in routine production***.”ii. You failed to adequately assess differences in product design and geometrical configurations of candidate devices for the adoption into device families of existing(b)(4)cleaning validations conducted by this supplier because you did not accurately answer guiding questions contained in your “Assessment of Product Change or New Product Adoption for Cleaning Processes” reports. For example: The AC-2772-01 (Rev. 01; Effective: 7/25/19) and AC-277D-01 (Rev. 2; Effective: 2/26/21) reports show that you failed to document rationale to support your answers of “no” to the question posed in section 2 – “In relation to the existing product, does the candidate product have a similar or less complex design?” – despite the candidate devices having 4 grooves, a drive, or a male thread compared to the worst-case and comparison devices, which have none of these features. The AC-2772-02 report (Rev. 1; Effective: 3/23/20) shows that you incorrectly answered “no” to the question posed in section 2 – “In relation to the existing product, does the candidate product have fewer/smaller or equivalent cannulated portions or lumens?” – when you compared the candidate device (segmental proximal femur, PF-2000L-02M), which has 7 cannulated holes, to the(b)(4)device ((b)(4)) and comparison devices ((b)(4)), which contain no holes.b.(b)(4)– Tier 1(b)(4)Cleaner of ELEOS Implant DevicesAlthough requested during the inspection, your Vice President of Quality Affairs and Regulatory Affairs was unable to provide documentation that you assessed the adequacy of the cleaning validations conducted in 2009 by this supplier,(b)(4). In reviewing the “Process Validation of***(b)(4)Clean Line” Operational Qualification (OQ) (E118-2116; Rev. 1; Approved: 1/9/09) and Performance Qualification (PQ) (E118-2116; Rev. 1; Approved: 2/3/09), the following deficiencies were observed:i. The rationale in the PQ report to accept deviations from the nominal operating range of(b)(4)°F ((b)(4), and(b)(4)°F) because OQ data showed that the process monitoring, total organic carbon (TOC), and gravimetric produced acceptable results at worst-case conditions for temperatures as low as(b)(4)°F and control charts indicated a lower control limit of(b)(4)°F (Deviation 3) does not take into account the vast differences in sample sizes ((b)(4)vs.(b)(4)) and acceptance criterion (Ppk(b)(4)vs. Ppk(b)(4)) between PQ and OQ for the same tests (TOC and gravimetric analysis) such that passing results for parameters established during OQ are not transferrable to PQ.ii. This supplier failed to document rationale in the OQ and PQ reports for why it was acceptable to convert all negative values measured for the corrected “mass recovered from gravimetric(b)(4)and corrected “mass recovered from(b)(4)to 0.00 mg in the “Gravimetric Extraction Summary” table during gravimetric testing, thereby passing the acceptance criteria of(b)(4)mg/cm2((b)(4)). For example, during OQ, an(b)(4)value as high as -1.59 mg for “Hip – 4” was converted to 0.00 mg without an explanation that accounts for the possibility of testing errors, inadequate test methodology (e.g., lack of sensitivity of testing methods), and uncalibrated state of measuring equipment.c.(b)(4)–(b)(4)Cleaner of ELEOS Implant Devices &(b)(4)Cleaner of ELEOS InstrumentsYou approved the adoption of new products into this supplier’s existing(b)(4)cleaning validations titled “(b)(4)Cleaning Equipment & Performance Qualification Report” (FR_920-001; Rev. B; Effective: 3/31/15) and “Zenith Final Ultrasonic Cleaning Equipment & Performance Qualification Report” (FR_920-001; Rev. B; Effective: 3/31/15) per your Cleaning, Assembly, Packaging and Sterility (CAPS) Checklists for Project # 16-001 (Approved 10/2/24) and Project # 16-003 (Approved 4/19/24) referencing memo “(b)(4)Cleaning” (2/14/19) and results of a 3rd party audit conducted 2/23/18 despite the following deficiencies:i. The OQ and PQ protocols failed to require documentation of the load configurations for all work orders in that the Vice President of Quality Affairs and Regulatory Affairs was not able to determine if devices were put in a(b)(4)or broken up into(b)(4).ii. The PQ protocol failed to include documentation of valid statistical rationale for cytotoxicity, endotoxin, and/or particulate testing. For example, the quantity tested per work order (66672, 66921, 66922) for cytotoxicity and endotoxin was(b)(4)and(b)(4)respectively and the quantity tested per work order (66675, 66919, 66920) for cytotoxicity, endotoxin, and particulate was(b)(4)and(b)(4), respectively.We reviewed your firm’s response and concluded that it is not adequate. The immediate correction is to impose heightened controls at each supplier commensurate with risk until new worst-case cleaning validations can be completed that addresses each of the observed deficiencies for(b)(4)by 1/15/26,(b)(4)(target date not provided), and(b)(4)by 3/1/26 at the latest.For(b)(4), an assessment of worst-case part justification by family was completed to establish new limits placed on(b)(4), and(b)(4). You plan to add this new loading criteria to the final DHR review by 7/15/25. In addition, you plan to require an update to(b)(4)internal procedure to include predicate cleaning validation review by 7/15/25. Based on the results of the new cleaning validation, you plan to revise top level procedures by(b)(4).For(b)(4), an assessment of worst-case part justification was conducted and monitoring was put in place to control product release by assessing endotoxicity and cytotoxicity on a(b)(4)basis. In addition, you plan to require an update to this supplier’s internal procedures to improve notification of triggers to their customers by 7/1/25.For(b)(4), you plan to conduct an assessment for worst-case part challenge per part family by(b)(4). For all instruments, interim clean line controls were implemented to require shipment of instruments to your firm and analyses of those instruments, which includes worst-case part and part family assessments prior to adoption into your clean-line part family. All parts successfully assessed will then be cleaned using your validated clean line prior to release for commercial distribution. All implants will continue to be shipped to(b)(4)for(b)(4)cleaning and will fall under controls established for therein.Corrective actions include updating your supplier control and design control procedures to establish minimum requirements for cleaning validations of implants and instruments, including defining key product attributes to consider when forming product families and what considerations trigger a new worst-case within a product family or new product cleaning family; creation of a procedure for part families and worst-case parts per family which defines and evaluates implant and instrument cleaning families to facilitate consistent assessment of device cleaning families across products; determination and justification of minimum sample size and attributes ((b)(4)) for validations; development of a cleaning validation checklist and modification of a supplier audit checklist that captures the aforementioned worst-case part determination, sample sizes, and minimum attributes that will be used during supplier assessment as part of design transfer and new supplier onboarding, manufacturing transfer, and supplier audit; and periodic review of validations on a scheduled interval against new standards and requirements by 6/15/25.However, no target date was provided for the new cleaning validation planned for(b)(4). Therefore, please provide a response regarding how you plan to address this deficiency. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).Specifically, you failed to implement your Post Market Surveillance procedure (QP-18-004; Rev. 3; Effective: 6/30/22) which requires opening a CAPA when the(b)(4)analysis of infection complaints “***is more than(b)(4)above the literature rate or(b)(4)are above the literature rate***” for a given procedure type. For example, you did not initiate CAPAs when the(b)(4)analysis for infection complaints exceeded the rates of(b)(4)% for the distal femur ((b)(4));(b)(4)% for proximal femur ((b)(4)and(b)(4)); and(b)(4)% for total femur ((b)(4)and(b)(4)) established in the journal article by Henderson et. al “Failure Mode Classification for Tumor Endoprostheses: Retrospective Review of Five Institutions and a Literature Review” (Journal Bone and Joint Surgery 2011) by(b)(4).The adequacy of the response dated 5/15/25 cannot be determined at this time. Under CAPA 24-011 which was initiated on 9/11/24 to create a more robust methodology for trending and analyzing infection related complaints, you conducted a revised retrospective assessment of(b)(4)infection rates from(b)(4)to(b)(4)(TM-25-0002; Rev. B; Approved 5/14/25) based on additional literature data to support updated baseline infection rates by procedure type. As a part of the corrective action, you plan to create new work instructions with requirements to perform(b)(4)trend reporting for infections and(b)(4)or(b)(4)trend reports for all other postmarket surveillance key performance indicators (KPIs); revise management review presentation slides and quality planning, postmarket surveillance, complaint handling, and CAPA procedures; and provide training on the new procedures. Please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.3. Failure to adequately establish and maintain procedures for validating the device design with regards to risk analysis, as required by 21 CFR 820.30(g).Specifically, you failed to implement section 5.9 of your “Risk Management Process” procedure (SOP-008; Rev. 4-5; Effective: 3/22/23 - 1/17/25) which requires postmarket re-evaluation of risk management for a medical device as well as monitoring of postmarket information “***for assurance that no unacceptable or previously unrecognized failure modes occur. In the event of such an occurrence the potential that the residual risk or its acceptability has changed and the impact on the previously implemented risk control measures shall be evaluated***.” For example, you failed to utilize the real rate of occurrence for loosening in complaints PCR 11272023-1 ((b)(4)), PCR 05132024-1 ((b)(4)), and PCR 10172024-1 ((b)(4)) calculated at 3.27%, 0.149%, and 3.1%, respectively, to evaluate the need to update the occurrence rating in the corresponding ELEOS Stem Implant Risk Table (Project # 16-001/16-003; Rev. E; Approved: 4/1/19), which remains unchanged at(b)(4)% through(b)(4)% since April 1, 2019.An update to the postmarket rate of occurrence changes the failure mode from an acceptable risk to a conditionally acceptable risk, thereby requiring an evaluation for the need for additional risk controls and assessment for the acceptability of the residual risk as required under sections 5.6 and 5.7 of SOP-008.The adequacy of the response dated 5/15/25 cannot be determined at this time. The immediate correction is to evaluate literature, sources, historical data, and/or engineering estimates against postmarket data and update the occurrence rates for the hazardous situations associated with the ELEOS Limb Salvage system by(b)(4)followed by a revision of the corresponding risk tables by(b)(4). As a part of the corrective action, you plan to revise SOP-008 to ensure that the methods used to create and maintain risk assessment tables are well-defined and create work instructions for conducting risk assessments utilizing postmarket information by(b)(4). Please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.4. Failure to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a).Specifically, you failed to implement section 1.1 of your “Sample Size and Statistical Techniques” procedure (SOP-014; Rev. 2-4; Effective: 8/16/18 - 3/22/23) which “***identifies valid statistical techniques that are used to establish, control and verify the acceptability of process capability and product characteristics***” pertaining to “***inspections and other analyses of objective data***” of ELEOS Implant Devices received from(b)(4). during incoming inspections. For example, your Vice President of Quality Affairs and Regulatory Affairs acknowledged that the sampling plans of the(b)(4)sampled incoming device history records (DHRs) from this supplier were not traceable to a documented valid statistical rationale.a. You reviewed and approved incoming DHRs for Lot #(b)(4)and Lot #(b)(4)on 11/2/20 and 11/29/21 where a sampling plan of(b)(4)was used to inspect critical features during in-process inspections for which there is no documented rationale for use of this sampling plan. For example, out of(b)(4)ELEOS Tibial Baseplate Component, Size 4 (Part # TB-2204E-01M) Implant Devices, the line profile (curve) for(b)(4)each were inspected against a specification of(b)(4)at(b)(4)for Lot #(b)(4). Similarly, out of(b)(4)ELEOS Collar, 28 Diameter, Round, Porous, HA Treated (Part # HB-2800R-03M) Implant Devices, the diameter for(b)(4)each was inspected against a specification of(b)(4)at(b)(4)for Lot #(b)(4).b. You reviewed and approved incoming DHRs (Lot #:(b)(4)) where sampling plans utilized an AQL (acceptable quality limit) of(b)(4)or(b)(4)to inspect features during in-process and final inspections for which there are no documented rationales for use of these sampling plans. For example, out of(b)(4)ELEOS Segmental Proximal Femur, Plasma Spray, Left 98 MM (Part # PF-2000L-02M) Implant Devices, the dimensional specification of(b)(4)was inspected at an AQL level of(b)(4)for Lot #(b)(4)during final inspection on 1/23/24.We reviewed your firm’s response and concluded that it is not adequate. The immediate corrections are to use a checklist to reassess and document rationales for acceptability of the existing AQLs selected for all contract manufactured ELEOS part families from 1/1/21 to 4/1/25 and share the rationales with the contract manufacturers by 11/21/25 and update SCAR 25-01 to require the contract manufacturer to include documented evidence for all inspected dimensions and associated AQL quantities by 5/14/25. As a part of the corrective actions, you plan to update SOP-014 and WI-013-31 (Incoming Inspection Process) to require review of incoming inspection results, consolidation of sampling procedures, set up traceable valid statistical rationales, and confirm AQLs by 7/6/25; update SOP-007 (Design Control) and various design transfer, manufacturing transfer, supplier, and incoming inspection checklists to include instructions for the acceptance of a supplier’s sampling procedure with confirmation of conformance to those procedures during incoming inspection of supplier DHRs by(b)(4); and develop(b)(4)inspection requirement checklists for all suppliers with a sampling procedure traceable to a valid statistical rationale based on(b)(4)by 7/18/25. However, these corrections and/or corrective actions only address the need to have a statistically valid rationale for the use of sampling plans which follow AQL and not sampling plans which utilize inspections of select critical features for the(b)(4)devices. Therefore, please provide a response on how you plan to address the above deficiency. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.Corrections and Removals Violation(s)Our inspection also revealed that your firm’s ELEOS Limb Salvage System devices 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, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:5. Failure to submit a medical device Report of Correction or Removal for an action initiated to reduce a risk to health posed by the device or remedy a violation which may present a risk to health, as required by 21 CFR Part 806.10. For example:a. Your firm conducted a removal of numerous part numbers and lot numbers of your ELEOS Limb Salvage System due to sterile packaging separation and damaged trays, which can result in extended surgery time or potential patient infection. Your firm sent a Customer Notification for this issue on 6/28/2023. This action meets the definition of a medical device correction or removal initiated to reduce a risk to health or remedy a violation which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. You did not submit a Medical Device Report of Correction or Removal to FDA for this action until after the investigation and citation.b. On or about 10/15/2024, your firm conducted a removal of your ELEOS Limb Salvage System, Male-Female Midsection 40MM, due to taper post misalignment, which can result in extended surgery time or improperly assembled devices leading to future disassociation. Your firm sent a Customer Notification for this issue dated 9/20/2024. This action meets the definition of a medical device correction or removal initiated to remedy a violation which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. You did not submit a Medical Device Report of Correction or Removal to FDA for this action until after the investigation and citation.c. On or about 1/22/2024, your firm conducted a removal of your ELEOS Limb Salvage System, Collar Stem, Cemented, Fluted 13MM X 120MM and Collar Stem, Cemented, Fluted 15MM X 120MM due to mislabeling of the devices, which can result in implantation or attempted implantation of an incorrect stem size, potentially extending surgery time or causing the patient to need revision surgery. Your firm sent a Customer Notification for this issue on 12/22/2023. This action meets the definition of a medical device correction or removal initiated to remedy a violation which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. You did not submit a Medical Device Report of Correction or Removal to FDA for this action until after the investigation and citation.The adequacy of your firm’s response, dated 5/14/2025, regarding Observation 5 cannot be determined because we do not have assurance that your firm will make appropriate decisions following 21 CFR 806 in the future, based on your firm’s root cause stating that your firm’s SOP is ambiguous and subjective. Your firm adequately reported by retroactively submitting Reports of Correction or Removal to FDA addressing each of the three issues on 4/25/2025.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 Gina Brackett, Establishment Assessment Team 1 (EAT-1) Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 712573” when replying. If you have any questions about the contents of this letter, please contact: Sargum C. Morgan, Compliance Officer at sargum.morgan@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 any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Matthew G. HillebrennerDeputy DirectorOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC: Len TokishVP of Quality Assurance & Regulatory Affairsltokish@onkossurgical.com

Product:DrugsRecipient:www.plakini-pharma.comMalaysiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: July 16, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.plakini-pharma.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)].As discussed below, FDA has observed that www.plakini-pharma.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.FDA has also observed that www.plakini-pharma.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co-use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co-used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.Finally, FDA has observed that www.plakini-pharma.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants via the Internet poses additional significant risks to U.S. consumers.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.plakinipharma.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.plakini-pharma.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.One example of an unapproved opioid you offer for sale on www.plakini-pharma.com is fentanyl, marketed as “Buy fentanyl patches 75mcg Online” and pictured as “fentanyl transdermal system.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy fentanyl patches 75mcg Online Fentanyl [sic] used for Fentanyl patches are used for long lasting pain relief for constant, around the clock cancer pain.” While there are FDA-approved versions of fentanyl on the market in the U.S., including for the transdermal route of administration, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy fentanyl patches 75mcg Online” offered by www.plakini-pharma.com. FDA-approved fentanyl is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. It is only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved fentanyl bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, lifethreatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when fentanyl is taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.Additional examples of unapproved opioids you offer for sale on www.plakini-pharma.com are:Hydrocodone marketed as “Buy Hydrocodone Online,” “Buy Hydrocodone Watson Online,” and “Hydrocodone Watson Online 853 espanol.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Buy Hydrocodone Online , [sic] Hydrocodone is an opioid used to treat pain and as a cough suppressant” and “Purchase Hydrocodone 853 español is a remedy pain relieving used to get moderate reasonably extreme agony [sic], and it’s regularly given in mix with acetaminophen.” While there are FDA-approved versions of hydrocodone on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Hydrocodone Online,” “Buy Hydrocodone Watson Online,” and “Hydrocodone Watson Online 853 espanol” offered by www.plakini-pharma.com.Tramadol marketed as “Buy original Tramadol 250mg,” “tramadol 50 mg,” and “TRAMADOL-X225.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy original Tramadol 250mg Tramadol, sold under the brand name Ultram among others, s [sic] an opioid pain medication used to treat moderate to moderately severe pain.” While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy original Tramadol 250mg,” “tramadol 50 mg,” and “TRAMADOL-X225” offered by www.plakini-pharma.com.Oxycodone marketed as “Buy Oxycodone 10mg Online,” “Buy Oxycodone 30mg (A215) Online,” “Buy Oxycodone 80mg Online,” and “OxyContin 80 mg.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “Buy Oxycodone 10mg Online Oxycodone… is an opioid medication used for treatment of moderate to severe pain,” “This help [sic] to keep you relief and is the world best pain medication Buy Oxycodone 30mg (A215) Online [sic],” “Onset of pain relief typically begins within fifteen minutes and lasts for up to six hours with the immediate-release formulation,” and “Buy Oxycodone 80mg Online Oxycodone... is an opioid medication used for treatment of moderate to severe pain.” While there are FDA-approved versions of oxycodone on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Oxycodone 10mg Online,” “Buy Oxycodone 30mg (A215) Online,” “Buy Oxycodone 80mg Online,” and “OxyContin 80 mg” offered by www.plakini-pharma.com.Oxycodone and acetaminophen marketed as “Buy Percocet 10mg online.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes its categorization under “RX Drugs.” While there are FDA-approved versions of oxycodone and acetaminophen on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Percocet 10mg online” offered by www.plakini-pharma.com.Hydromorphone marketed as “Buy high quality Dilaudid 8mg.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy high quality Dilaudid 8mg, Dilaudid is a potent opioid analgesic used to treat moderate and severe pain. The drug influences the human brain, blocking its response to pain.” While there are FDA-approved versions of hydromorphone on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy high quality Dilaudid 8mg” offered by www.plakini-pharma.com.FDA-approved hydrocodone, tramadol, oxycodone, and brand names OXYCONTIN, PERCOCET, and DILAUDID, are each indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. They are only available pursuant to a prescription from a licensed practitioner.Furthermore, FDA-approved hydrocodone, oxycodone, tramadol, OXYCONTIN, PERCOCET, and DILAUDID each bear a boxed warning, addressing risks including addiction, abuse, misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, and accidental exposure resulting in death. In addition, when hydrocodone, tramadol, oxycodone, OXYCONTIN, PERCOCET, or DILAUDID is taken in conjunction with other CNS depressants, including alcohol and benzodiazepines, use may result in coma or death.An example of an unapproved benzodiazepine you offer for sale on www.plakini-pharma.com is flunitrazepam marketed as “Buy Rohypnol Online” and “Rohypnol Flunitrazepam 1 mg 30 Filmtabletten.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy Rohypnol Online Rohypnol, also known as flunitrazepam among other names [sic] benzodiazepine used to treat severe insomnia and assist with anesthesia.” While there are FDA-approved benzodiazepine drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for flunitrazepam. FDA-approved benzodiazepine drug products are only available pursuant to a prescription from a licensed practitioner. Benzodiazepines also bear a boxed warning, addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Two examples of unapproved Schedule II stimulants you offer for sale on www.plakini-pharma.com are:Amphetamine marketed as “Buy Adderall 20mg (XR),” “Buy Adderall 20mg IR online,” “Buy Adderall 25mg XR online,” and “Buy Adderall 30mg IR online.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “Adderall is generally well tolerated and effective in treating the symptoms of ADHD and narcolepsy. At therapeutic doses, Adderall causes emotional and cognitive effects such as euphoria, change in sex drive, increased wakefulness, and improved cognitive control,” “Buy Adderall 20mg IR online of one of the best retailers online at the best price. [sic] is also known as amphetamine and dextroamphetamine used for the treatment of ADHD,” and “It is also used as an athletic performance enhancer and cognitive enhancer, and recreationally as an aphrodisiac and euphoriant.” While there are FDA-approved versions of amphetamine on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Adderall 20mg (XR),” “Buy Adderall 20mg IR online,” “Buy Adderall 25mg XR online,” and “Buy Adderall 30mg IR online” offered by www.plakini-pharma.com.Methylphenidate marketed as “Buy Ritalin 10mg online,” “Ritalin 10 30 Tablette,” and “Ritalin tablet 10 mg 3x10s.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy Ritalin 10mg online Methylphenidate, sold under the brand names Ritalin and Concerta among others, is a central nervous system (CNS) stimulant medication used to treat attention deficit hyperactivity disorder (ADHD) and, to a lesser extent, Ritalin methylphenidate 10mg online narcolepsy [sic].” While there are FDA-approved versions of methylphenidate on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Ritalin 10mg online,” “Ritalin 10 30 Tablette,” and “Ritalin tablet 10 mg 3x10s” offered by www.plakini-pharma.com.ADDERALL and RITALIN are brand names for FDA-approved drugs indicated for the treatment of attention deficit hyperactivity disorders and narcolepsy. Using the brand name of the drug products ADDERALL and RITALIN indicates that these products are intended to treat attention deficit hyperactivity disorder and narcolepsy. FDAapproved ADDERALL and RITALIN are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved ADDERALL and RITALIN each bear a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, ADDERALL and RITALIN can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including ADDERALL and RITALIN, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.plakini-pharma.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.plakini-pharma.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately addressthis matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:www.mysteroidsmarket.comIsraelIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: July 17, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.mysteroidsmarket.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].As discussed below, FDA has observed that www.mysteroidsmarket.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants and benzodiazepines. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants.Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines. The easy availability of Schedule II stimulants and benzodiazepines via the Internet poses additional significant risks to U.S. consumers.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.mysteroidsmarket.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.mysteroidsmarket.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved Schedule II stimulant you offer for sale on www.mysteroidsmarket.com is amphetamine marketed as “Buy Adderall Xr 30mg” and “ADDERALL XR®.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “a medication commonly prescribed to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy.” While there are FDA-approved versions of amphetamine on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Adderall Xr 30mg” and “ADDERALL XR®” offered by www.mysteroidsmarket.com. ADDERALL XR is the brand name for the FDA-approved drug indicated for the treatment of attention deficit hyperactivity disorder (ADHD). It is only available pursuant to a prescription from a licensed practitioner. Using the trade name of the drug product ADDERALL XR indicates that this product is intended to treat attention deficit hyperactivity disorder. Furthermore, FDA-approved ADDERALL XR bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including abuse, misuse, and addiction. In addition, ADDERALL XR can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of central nervous system (CNS) stimulants, including ADDERALL XR, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.An example of an unapproved benzodiazepine you offer for sale on www.mysteroidsmarket.com is clonazepam marketed as “Buy Clonazepam 0.5mg,” “CLONAZEPAM 0,5 mg,” “Buy Clonazepam 1mg,” “Clonazepam Neuraxpharm 1 mg,” “Buy Clonazepam 2mg,” and “Clonazepam Tableta 2 mg.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “primarily prescribed to treat seizure disorders, panic disorder, and certain types of movement disorders” and “which act on the central nervous system to produce a calming effect.” While there are FDA-approved versions of clonazepam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Clonazepam 0.5mg,” “CLONAZEPAM 0,5 mg,” “Buy Clonazepam 1mg,” “Clonazepam Neuraxpharm 1 mg,” “Buy Clonazepam 2mg,” and “Clonazepam Tableta 2 mg” offered by www.mysteroidsmarket.com. FDA-approved clonazepam, including the brand name KLONOPIN, is indicated for the treatment of certain seizures and of panic disorder, with or without agoraphobia, as defined in DSM-V.Another example of an unapproved benzodiazepine you offer for sale on www.mysteroidsmarket.com is lorazepam marketed as “Buy Ativan Lorazepam 1mg,” “Ativán® lorazepam Tabletas 1 mg,” “Buy Ativan Lorazepam 2mg,” and “Ativan (Lorazepam) 2mg.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “primarily prescribed to manage anxiety disorders, including generalized anxiety disorder (GAD) and panic disorder” and “used as a short-term treatment for insomnia, seizures, and to help with symptoms of alcohol withdrawal.” While there are FDA-approved versions of lorazepam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Ativan Lorazepam 1mg,” “Ativán® lorazepam Tabletas 1 mg,” “Buy Ativan Lorazepam 2mg,” and “Ativan (Lorazepam) 2mg” offered by www.mysteroidsmarket.com. FDA-approved lorazepam, including the brand name ATIVAN, is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.FDA-approved clonazepam and lorazepam are benzodiazepine drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved clonazepam and lorazepam each bear a boxed warning, addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.mysteroidsmarket.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].Additionally, FDA has observed that the www.mysteroidsmarket.com offers prescription drugs for sale without a prescription. Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.mysteroidsmarket.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.mysteroidsmarket.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

广东邦泽医药有限公司生产的造口皮肤保护剂，生产批号见附件，因说产品标签、说明书上的适用范围与备案内容不一致，决定对售出产品实施召回，召回级别为三级。　　涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　附件：医疗器械召回事件报告表　　2025年7月29日

广东邦泽医药有限公司生产的导光凝胶，生产批号见附件，因说产品标签、说明书上的适用范围与备案内容不一致，决定对售出产品实施召回，召回级别为三级。　　涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　附件：医疗器械召回事件报告表　　2025年7月29日

（通告 2025年第19号）按照《药品管理法》及《国家药监局关于实施新修订有关事项的公告》（2020年第47号）要求，经现场检查黑龙江国药天江药业有限公司等9家企业符合《药品生产质量管理规范（2010年修订）》要求。特此通告。附件：药品GMP符合性检查企业目录（2025年 第7号）黑龙江省药品监督管理局2025年7月29日序号符合性检查编号企业名称检查范围生产地址现场检查时间备注1黑药符查2025057黑龙江国药天江药业有限公司饮片车间普通饮片生产线：中药饮片（净制、切制、炮炙（炒（清炒、麸炒）、炙法（酒炙、醋炙、盐炙、蜜炙）、制炭（炒炭）、煅（煅淬）、蒸、其他（燀）)）;饮片车间毒性饮片生产线：毒性中药饮片（净制、切制、煮）黑龙江省哈尔滨市利民开发区北盛路1777号2025年6月20日-6月22日2黑药符查2025044黑龙江省松花江医药科技有限公司冻干粉针车间C生产线、冻干粉针车间D生产线、前处理一车间前处理生产线、提取一车间一线：冻干粉针剂（含中药材前处理及中药提取）(与黑龙江珍宝岛药业股份有限公司鸡西分公司共用)黑龙江省鸡西市虎林市动力街68号黑龙江省鸡西市鸡冠区鸡恒路69号2025年5月15日至5月18日3黑药符查2025051哈尔滨大洋制药股份有限公司中药提取车间中药提取生产线，口服固体制剂车间片剂生产线、胶囊剂生产线、颗粒剂生产线:片剂、胶囊剂、颗粒剂（含中药提取）哈尔滨市开发区哈平路集中区威海路3号2025年6月9日至6月11日4黑药符查2025055黑龙江珍宝岛药业股份有限公司综合制剂一车间口服液C生产线、前处理一车间前处理生产线、提取一车间二线:糖浆剂(含中药材前处理及中药提取)(与黑龙江珍宝岛药业股份有限公司鸡西分公司共用)黑龙江省虎林市红星街72号（制剂）黑龙江省鸡西市鸡冠区鸡恒路69号（中药前处理及提取）2025年6月12日—14日5黑药符查2025052黑龙江易佰药业有限公司固体制剂一车间片剂生产线、提取车间提取生产线：片剂（含中药提取）（委托生产品种：益脑宁片（规格：基片重0.35g；国药准字Z23023221)、益脑宁片（规格：每片重0.37g；国药准字Z20083093)）黑龙江省哈尔滨市高新技术产业开发区迎宾路集中区太行路2号综合楼407室（委托方）；哈尔滨高新技术产业开发区迎宾路集中区太湖北街15号（受托方）2025年6月19日-23日6黑药符查2025050大兴安岭利沃康药业有限公司原料药(水飞蓟素)生产车间、原料药（水飞蓟素）生产线、原料药(水飞蓟素)黑龙江省大兴安岭地区呼玛县创新南街1号2025年6月14日—16日7黑药符查2025037将铭（黑龙江）制药有限公司合剂（含中药提取)哈尔滨利民开发区沈阳大街哈尔滨医科大学科技园2025年5月7日-5月11日委托哈尔滨医大药业股份有限公司生产银黄口服液（规格：每支装10ml）8黑药符查2025053佳木斯华润三九中医药传承创新有限责任公司饮片车间饮片生产线：中药饮片（净制、切制）黑龙江省佳木斯市东风区胜利东路1999号 2025年6月13日-15日9黑药符查2025040伊春五加参药业有限责任公司固体制剂车间片剂生产线、硬胶囊剂生产线、软胶囊剂生产线、颗粒剂生产线、浸膏剂生产线，中药材前处理及中药提取车间中药材前处理及中药提取生产线：片剂、硬胶囊剂、软胶囊剂、颗粒剂、浸膏剂（含中药材前处理及中药提取车间）；饮片生产车间饮片生产线：中药饮片：净制、切制、炮炙（炒、酒炙、醋炙、盐炙、姜炙、蜜炙、油炙、制炭、煅、蒸、煮、炖、煨、焊、制霜、水飞、发芽、发酵），毒性饮片：净制、切制、炮炙（炒、醋炙、蒸、煮、制霜、水飞）符合要求。黑龙江省伊春市南岔区东升街2号2025年5月23日-5月24日,6月10日-6月11日。

（通告 2025年第20号）根据《国家药监局 农业农村部 国家林草局 国家中医药局关于发布特此通告。黑龙江省药品监督管理局2025年7月29日附件中药材GAP符合性延伸检查结果序号被检查主体中药材品种基地建设单位基地面积（亩）基地地址经纬度坐标检查结果1黑龙江森工药业有限责任公司哈尔滨市方圣医药科技有限公司黑龙江羽迪药业有限责任公司黑龙江金九药业股份有限公司刺五加东方红林业局有限公司3.48万虎林市东方红镇东经132°27′-134°05′北纬46°10′-47°01′符合要求2黑龙江全乐制药有限公司刺五加虎林市全乐中草药种植专业合作社（合作联社）5万虎林市八五四农场工业区；虎林市杨岗镇七虎林林场；虎林市东方红林业局东林林场。种植A区域：东经132°19 50.1北纬45°54 06.4种植B区域：东经132°21 18.4北纬45°54 23.6种植C区域：东经132°21 22.8北纬45°54 04.1种植D区域：东经132°19 44.3北纬45°53 56.7种植E区域：东经132°19 24.5北纬45°53 32.9符合要求3黑龙江省格润药业有限责任公司哈药集团世一堂制药厂哈药集团中药二厂刺五加伊春森林百草园中药材种植有限公司5538.8伊春市南岔县奋斗经营所 1132林班：671.8亩（东经129°09'52"—129°10'10"，北纬47°15'40"—47°16'53"）；133林班：910.8亩（东经129°08'30"—129°09'01"，北纬47°16'17"—47°17'27"）；135林班：909.6亩（东经129°06'47"—129°07'31"，北纬47°16'22"—47°17'31"）；150林班：1022.2亩（东经129°06'46"—129°06'12"，北纬47°18'32"—47°19'18"）；159林班：910.6亩（东经129°05'02"—129°04'59"，北纬47°20'56"—47°22'07"）；176林班：1113.8亩（东经129°06'46"—129°07'29"，北纬47°20'25"—47°21'41"）。符合要求4黑龙江新医圣制药有限公司刺五加黑龙江众春堂生物科技有限责任公司（自主建设基地）10681鸡东县永和镇四山林场；鸡东县平阳镇凤凰山林场；鸡东县兴农镇宝泉林场；鸡东县永和镇平房林场。四山林场：东经131°08′-132°53′ ,北纬44°96′-45°18′；宝泉林场：东经130°96′-131°00′,北纬45°59′-45°62′；平房林场：东经130°86′-131°06′,北纬45°02′-45°95′；凤凰山林场：东经131°31′- 132°51′,北纬45°01′-45°95′。符合要求5黑龙江乌苏里江制药有限公司刺五加黑龙江乌苏里江制药有限公司（自主建设）3.5万虎林市杨岗镇七虎林林场；虎林市杨岗镇杨岗示范林场。虎林市杨岗镇七虎林林场：北纬45°54′27.36″-45°59′4.92″，东经132°21′1.44″-132°27′22.68″；虎林市杨岗镇杨岗示范林场：北纬45°44′18.60″-45°45′38.16″，东经132°15′9.36″-132°18′6.48″。符合要求

根据《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》《药品检查管理办法（试行）》《药品经营质量管理规范》等有关法律法规规范，以及《云南省药品监督管理局关于2025年全省药品经营企业监督检查计划的通知》要求，云南省药品监督管理局对45家药品批发（零售连锁总部）企业开展了药品常规检查，现将检查结果通告如下：序号企业名称经营方式检查类型检查时间检查结果采取措施1旭力中嘉（云南）医药有限公司批发常规检查2025年5月7-8日符合要求2桂康云南医药有限责任公司批发常规检查2025年5月7-8日符合要求3云南润康药业有限公司批发常规检查2025年5月7-8日符合要求4云南万源医药有限公司批发常规检查2025年4月21-22日符合要求5云南省医药万和有限公司批发常规检查2025年4月25-26日符合要求6昭通市雄风药业有限公司批发常规检查2025年4月22-24日符合要求7云南同云堂医药有限公司批发常规检查2025年4月22-24日符合要求8云南同云堂医药有限公司零售连锁总部常规检查2025年4月22-24日符合要求9云南华榕医药有限公司批发常规检查2025年4月22-23日符合要求10云南龙马药业有限公司批发常规检查2025年4月23-24日符合要求11云南白药集团股份有限公司中药饮片分公司批发（非法人）常规检查2025年4月23-24日符合要求12云南韩康医药有限公司批发常规检查2025年4月21日符合要求13云南万丰医药有限公司批发常规检查2025年4月21-22日符合要求14云南鸿翔中药科技有限公司批发常规检查2025年4月23-24日符合要求15昆明天利和药业有限公司批发常规检查2025年4月16-17日符合要求16昆明福林堂药业有限公司批发常规检查2025年4月16-18日符合要求17云南顺康药业有限公司批发常规检查2025年4月15-17日符合要求18昆明福林堂药业有限公司零售连锁总部常规检查2025年4月16-18日符合要求19楚雄州虹成药业有限公司批发常规检查2025年4月10-12日符合要求20楚雄虹成连锁药品零售有限公司零售连锁总部常规检查2025年4月10-12日符合要求21云南昊邦医药销售有限公司零售连锁总部常规检查2025年4月7-9日符合要求22云南昊邦医药销售有限公司批发常规检查2025年4月7-9日符合要求23云南聚乐医药有限公司批发常规检查2025年4月8-9日符合要求24云南靖兴药业集团有限公司批发常规检查2025年4月10-12日符合要求25曲靖市益寿堂医药有限公司批发常规检查2025年4月13-15日符合要求26云南青荷医药有限公司批发常规检查2025年4月9-10日符合要求27云南瑞扬医药有限公司批发常规检查2025年4月8-9日符合要求28云南中盈现代医药物流有限公司批发常规检查2025年4月7-9日符合要求29云南诚至誉药业有限公司批发常规检查2025年3月27-28日符合要求30国药控股云南有限公司批发常规检查2025年3月24-26日符合要求31云南省玉溪医药有限责任公司批发常规检查2025年3月26-29日符合要求32云南省玉溪医药有限责任公司零售连锁总部常规检查2025年3月26-29日符合要求33华润昆明医药有限公司批发常规检查2025年3月14-16日符合要求34一心堂药业集团股份有限公司零售连锁总部常规检查2025年3月10-12日符合要求35一心堂药业集团股份有限公司批发常规检查2025年3月10-12日符合要求36一心堂药业昆明有限公司零售连锁总部常规检查2025年3月13-14日符合要求37云南省医药有限公司批发常规检查2025年3月10-13日符合要求38云南省医药昭通有限公司批发常规检查2025年3月11-12日符合要求39云南省医药大理有限公司批发常规检查2025年3月10-11日符合要求40昆明悦来达医药有限责任公司批发常规检查2025年3月10-12日符合要求41鹤庆县云鹤医疗投资有限公司批发常规检查2025年3月13-15日符合要求42云南医药工业销售有限公司批发常规检查2025年3月13-15日符合要求43云南汇丰祥医药控股集团有限公司批发常规检查2025年2月25-26日符合要求44昆明泰和医药有限公司批发常规检查2025年4月10-11日不符合要求采取责令整改风险控制措施，涉嫌违法线索已在调查45云南医药卫生有限公司批发常规检查2025年5月7日-8日终止检查采取暂停经营风险控制措施，涉嫌违法线索已在调查云南省药品监督管理局2025年7月25日

行政相对人名称×××公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)×××法定代表人×××法定代表人证件类型身份证法定代表人证件号码×××行政处罚决定书文号粤药监妆罚〔2025〕2010号违法行为类型生产未经注册的特殊化妆品违法事实当事人于2022年11月至2023年12月期间，共生产了32批次未经注册的特殊化妆品魔歌染发膏。当事人生产的上述32批次涉案产品共收取加工费***元，总货值金额为***元。因由2批次涉案产品前期已处罚完毕，故不再将上述2批次化妆品的违法所得及货值金额纳入。本案中当事人生产的其余30批次涉案产品共收取加工费***元，总货值金额为***元，违法所得***元。在化妆品监管部门现场调查时，当事人多次通过出具《样品真实性异议申请书》《产品假冒情况说明》等方式否认部分涉案产品是其生产的，当事人存在多次提供虚假信息、隐瞒真实情况的违法行为。依据《化妆品生产经营监督管理办法》第六十一条第一款第二项：“有下列情形之一的，属于化妆品监督管理条例规定的情节严重情形：（二）故意提供虚假信息或者隐瞒真实情况”的规定，当事人上述多次提供虚假信息、隐瞒真实情况，符合情节严重的情形。处罚依据《化妆品监督管理条例》第五十九条第二项处罚类别责令停产停业，吊销许可证件，限制从业。处罚内容除本局及属地市场监管部门已对当事人及相关责任人作出的行政处罚外，本局决定对当事人作出如下处罚：1.责令停止化妆品经营6个月；2.吊销化妆品生产许可证（粤妆20220288）；3.10年内不予办理其提出的化妆品备案或者受理其提出的化妆品行政许可申请。罚款金额（万元）0没收违法所得、没收非法财物的金额（万元）0暂扣或吊销证照名称及编号化妆品生产许可证（编号：粤妆20220288）处罚决定日期2025年7月15日处罚有效期10年公示截止期2035年7月15日处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421

行政相对人名称×××公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)×××法定代表人×××法定代表人证件类型身份证法定代表人证件号码×××行政处罚决定书文号粤药监妆罚〔2025〕2013号违法行为类型生产经营不符合化妆品注册资料载明的技术要求的化妆品违法事实当事人因生产不符合化妆品注册资料载明的技术要求的化妆品于2023年9月27日受到属地市场监管部门的行政处罚，而当事人于2023年11月3日生产的SCHHUBBI美白奢润轻透光彩隔离精华防晒乳产品（批号：CIK0341a、限期使用日期：20261102），经检验该产品又不符合化妆品注册资料载明的技术要求，依据《化妆品生产经营监督管理办法》第六十一条第一款第（四）项：“有下列情形之一的，属于化妆品监督管理条例规定的情节严重情形：......（四）因化妆品违法行为受到行政处罚后1年内又实施同一性质的违法行为......”的规定，当事人上述违法行为符合情节严重情形。此外，当事人2023-2024年期间共有9批次产品抽检不合格，涉及不符合化妆品注册资料载明的技术要求的化妆品4批次和未经注册的特殊化妆品5批次，当事人的违法行为持续发生。处罚依据《化妆品监督管理条例》第六十条第二项处罚类别责令停产停业，吊销许可证件。处罚内容除本局及属地市场监管部门已对当事人及相关责任人作出的行政处罚外，本局决定对当事人作出如下处罚：1.责令停止经营化妆品6个月；2.吊销化妆品生产许可证（编号：粤妆20160709）。罚款金额（万元）0没收违法所得、没收非法财物的金额（万元）0暂扣或吊销证照名称及编号化妆品生产许可证（编号：粤妆20160709）处罚决定日期2025年7月11日处罚有效期10年公示截止期2035年7月11日处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421