Delivery Method:VIA Electronic MailReference #:320-25-85Product:DrugsRecipient:Mr. Ali MithavayaniOwner/Chief Executive Officer (CEO)Xtreme Tools International, Inc.15400 NW 34th AvenueOpa Locka,FL33054-2461United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-85June 25, 2025Dear Mr. Mithavayani:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Xtreme Tools International, Inc., FEI 3010314796, located at 15400 NW 34th Avenue, Opa Locka, from January 27 to 31, 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 February 20, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP and support the products currently on the U.S. market within expiry.CGMP Violations1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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)).Inadequate Component TestingYour firm failed to ensure that incoming component lots were suitable for used in manufacturing your over-the-counter (OTC) topical drug products. For example, your firm used salicylic acid active pharmaceutical ingredient (API) to manufacture Okay Miami Salicylic Acid Foaming Scrub, based on a component supplier’s certificate of analysis (COA). However, you did not perform identity testing, nor did you verify your supplier’s test results at appropriate intervals.In addition, your firm uses(b)(4)water as a component in the manufacture of your drug products. Your firm has not demonstrated that the water is suitable for its intended use for pharmaceutical manufacturing and meets the Purified Water, USP monograph for chemical and microbiological attributes.Glycerin and Propylene GlycolYou failed to adequately test each shipment of each lot of glycerin and propylene glycol for identity, components at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. Identity testing for glycerin, propylene glycol, and certain other high-risk drug components1includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform adequate 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 manufacture of your drug product.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.Without adequate testing, you do not have appropriate assurance that components conform to appropriate specifications prior to use in the drug products you manufacture.2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).Your firm failed to conduct adequate finished product release testing for each batch of your drug products, including but not limited to, testing the identity and strength of the active ingredients, and testing for objectionable microorganisms.Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to appropriate specifications before release.3. 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)).Your firm failed to adequately validate the manufacturing processes used in the production of your drug products, including qualifying your manufacturing equipment. Likewise, you lacked appropriate documentation of qualification, and maintenance for your(b)(4)water system, which is used in the manufacture of your drug products.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 FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:Establishment of procedures describing roles and responsibilities of the QU including, but not limited to, batch release, investigations, change control, complaint handling, periodic product reviews, training, and reserve sampling (21 CFR 211.22(d)).Establishment of an appropriate program for cleaning and maintenance of equipment (21 CFR 211.67(b)).Establishment of an appropriate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Your firm’s quality systems are inadequate. 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.Drug Production CeasedWe acknowledge your commitment to cease production of all drugs at this facility.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. Should you resume manufacturing drugs, based 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 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.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 3010314796 and ATTN: Christopher M. Jenner.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research__________________1Components with higher risk of DEG or EG contamination compared to other drug components.

Delivery Method:VIA Electronic MailReference #:320-25-87Product:DrugsRecipient:Ms. Susan Carol Libby PresidentPresidentLibby Laboratories, Inc.1700 Sixth StreetBerkeley,CA94710United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-87June 27, 2025Dear Ms. Libby:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Libby Laboratories, Inc., FEI 2912388, at 1700 Sixth Street, Berkeley, California, from March 11 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 April 1, 2025 response to our Form FDA 483 in detail.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to conduct for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).You manufacture over-the-counter (OTC) sunscreen and(b)(4)drug products. Your(b)(4)antiseptic is labeled for hospital use only and used to prepare skin prior to surgery. You released your(b)(4)drug product batches without testing for microbiological quality. For example, the batch record for finished product batch(b)(4), manufactured in September 2024 and distributed to a children’s hospital, only lists finished drug product tests for(b)(4)assay, color, odor, appearance, and percentage of(b)(4).Without testing each batch prior to release, you did not have scientific evidence that all drug product batches were free of microbial contamination that is objectionable in view of its intended use.In your response, you state that your(b)(4)product contains(b)(4)and(b)(4), which are bactericidal. You indicate that you “think that the requirement to have finished product tested for presence of objectionable microorganisms is not necessary.” You commit to testing your finished drug product for objectionable microorganisms prior to releasing any future batches.Your response is inadequate. You did not provide an appropriate scientific basis to support that your finished drug products are free from microbial growth or survival. Additionally, you did not provide any retrospective testing to support the quality of your drug products currently on the market.In response to this letter, provide the following:A list of chemical and microbiological specifications, including test methods, used to analyze each batch of your drug products before batch disposition decisions.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 in the United States that are within expiry as of the date of this letter.o A summary of all results obtained from retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 failed to perform adequate identity testing of each component lot used in the manufacture of your OTC drug products, such as(b)(4)and(b)(4). You also relied on your suppliers’ certificate of analysis (COA) for components, such as(b)(4), and(b)(4), without establishing the reliability of the suppliers’ test analyses at appropriate intervals.Furthermore, we note that you used(b)(4)purchased from a local grocery store as a component in the manufacture of your drug products for which you only conducted organoleptic assessment, including color, odor and appearance. This practice is unacceptable for pharmaceutical manufacturing. At a minimum, you must use purified water (refer to USP General Chapter Water for Pharmaceutical Purposes) to manufacture your topical, non-sterile drug products. Pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.(b)(4)You failed to adequately test each shipment of each lot of(b)(4)for identity, a component at high-risk of(b)(4)or(b)(4)contamination. Identity testing for(b)(4)and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for levels of(b)(4)or(b)(4). 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 this component for use in the manufacture of your drug products.The use of ingredients contaminated with(b)(4)or(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4)to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for(b)(4)or(b)(4)contamination at(b)(4)(b)(4)You failed to adequately test your incoming(b)(4), used as an active pharmaceutical ingredient, for(b)(4). The use of(b)(4)contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4).Without adequate testing, you do not have scientific evidence that components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality.In your response, you state that you plan to use contract laboratories to perform the identity tests for(b)(4)and(b)(4). You also plan to test your drug components in-house or via a contract testing laboratory using compendial test methods or test methods from the manufacturers’ COA.Your response is inadequate because you fail to address the full scope and impact of the CGMP deficiencies as well as the associated risks to drug product quality, including batches already in distribution. Your response also lacked adequate information on how you will evaluate the suitability of your in-house laboratory or contract laboratories to perform testing of your drug components.In response to this letter, provide the following: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 components 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 robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.A commitment to provide(b)(4)and(b)(4)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(b)(4)and(b)(4).A full risk assessment for drug products that are within expiry which contain any ingredient at risk for(b)(4)or(b)(4)contamination (including, but not limited to,(b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain(b)(4)or(b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action (CAPA) 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.Provide scientific justification to demonstrate the(b)(4)you use is suitable for use in drug manufacturing operations. If you determine the(b)(4)you used to manufacture drugs was not suitable, provide a detailed risk assessment addressing the potential effects on the quality of all drug product lots currently in U.S. distribution and within expiry. Specify actions you will take in response to the risk assessment.Quality SystemsYour firm’s quality systems are inadequate. 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/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.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.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.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 2912388 and ATTN: Emily Wu.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailReference #:320-25-88Product:DrugsRecipient:Phanesh Koneru, PhD, LL.M.President and CEOExela Pharma Sciences, LLC1245 Blowing Rock BlvdLenoir,NC28645-3618United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-88July 2, 2025Dear Dr. Koneru:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Exela Pharma Sciences, FEI 3008563008, at 1245 Blowing Rock Blvd, Lenoir, NC 28645, from November 4, 2024, to November 15, 2024.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals based on observations made at that time and our subsequent analysis. 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 December 9, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.I. Drug Manufacturing OperationsYour facility is registered under section 510 of the FD&C ACT and manufactures multiple drug products pursuant to New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA).This section summarizes significant violations of CGMP regulations for finished pharmaceuticals you manufacture. See 21 CFR parts 210 and 211.FDA investigators documented CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The violations include, for example: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).a. You invalidated, without an adequate root cause investigation, failing growth promotion results, which are used to determine suitability of media used for sterility testing of finished drug products.(b)(4), lot(b)(4), was used in the release sterility testing of multiple application drug products, including, but not limited to, ephedrine sulfate injection 5 mg/mL, potassium acetate injection 2 mEq/mL, folic acid injection 5 mg/mL, tranexamic acid injection 10 mg/mL, cupric chloride injection 1 mg/mL, glycopyrrolate injection 0.2 mg/mL, sodium bicarbonate injection 1 mEq/mL, nicardipine HCl 2.5 mg/mL, fentanyl citrate injection 50 mcg/mL, sodium nitroprusside injection 0.2 mg/mL, streptomycin injection, ibuprofen lysine injection 10 mg/mL, caffeine citrate injection 20 mg/mL, palonosetron HCl 0.125 mg/mL, pentamidine isethionate for inhalation, zinc chloride injection, and argatroban injection 100 mg/mL, despite growth promotion testing failing twice and passing on a third test. Your investigation concluded there was no product impact because retesting of the media ultimately achieved passing results. Your investigation documented human performance as the cause of the failing testing events for(b)(4), lot(b)(4), and(b)(4)other media lots; however, no specific human error was identified.Your initial response acknowledged the investigation did not adequately document the evidence supporting the identified root cause despite the availability of test data. You also committed to revise SOP-000147 to require investigations for any confirmed or unconfirmed growth promotion failure and you plan to hire a third-party consultant to perform a retrospective review of investigations and train personnel.Your initial response was inadequate. Your initial response did not include a copy of your revised procedure for “Quality Control Testing of Microbiological Test Media”, SOP-000147, to support your commitments to require investigations for all test failures and associated training for all analysts. Additionally, your investigation does not include a review of all failing growth promotion media for all application drug product batches tested using these media lots. Your initial response also did not provide protocols for your proposed retrospective assessments.b. You invalidated, without an adequate root cause investigation, out-of-specification (OOS) results for sub-visible particulate matter testing of(b)(4)batches of sodium bicarbonate injection when one of(b)(4)vials failed. Your investigation documented that(b)(4)were observed in the sample(b)(4)for the failing vial, and the analyst was instructed to(b)(4)the line to clear the(b)(4). When a retest of the vial did not confirm the original results, you prepared new vials which gave passing results. Although you identified the root cause as related to human error, no corrective action or training was implemented to prevent recurrence.Your initial response stated the root cause was due to(b)(4)in the sample(b)(4)and acknowledged that the analyst failed to follow the procedure. You stated you will revise your testing procedure “to include(b)(4)requirement for product that contains(b)(4)” … “to address any future human errors related to the dissipation of(b)(4)for particulate matter analysis.”Your initial response was inadequate. Although your response indicates there were two quality events (QE) in a 10-day span due to OOS (high) particulate matter counts, your investigation determined there was no “formal” trend and no corrective action was needed. The second QE-000622 included “(b)(4)” of the analyst to understand the importance of allowing time for(b)(4). However, your initial response did not include a copy of your revised procedure, QCMET-000074, “Determination of Particulate Matter in Finished Drug Products,” and documentation to show all analysts who perform this test method have been retrained to prevent recurrence.In response to this letter, provide:A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for US 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 Quality unit oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identifiedo Adequately scoping of each investigation and its CAPAo Revised OOS investigation procedures with these and other remediations2. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).You failed to accurately document microbiology testing results. In addition, test results are not verified by a second person for accuracy. Specifically, on November 6, 2024, your analyst recorded fewer colony forming units for active air environmental monitoring samples than what was observed by our investigator during the examination. An independent review of the plate count by a second analyst to assure accuracy of the data was not conducted.Reliability of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results. Furthermore, the lack of reliable data compromises the quality unit’s ability to exercise its function of ensuring compliance to applicable standards.Your initial response acknowledged “a secondary, contemporaneous verification of environmental monitoring samples is fundamental to maintaining the integrity of such data.” You also committed to revise your procedures to require a second person review for all tests and to perform a retrospective review of “microbiology laboratory activities to identify activities that are not currently recorded electronically or contemporaneously.”Your initial response was inadequate because it failed to address the misread plate counts observed during the inspection for viable air and identify corrective and preventative actions for this failure. Moreover, your response lacks an assessment of potential data integrity concerns associated with one-person verification.In response to this letter, provide:A comprehensive assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.II. Outsourcing Facility OperationsYou also registered your facility with FDA as an outsourcing facility under section 503B of the FD&C Act [21 U.S.C. § 353b]1on June 6, 2014, initially, and most recently on January 1, 2024. Your facility deregistered as an outsourcing facility on December 20, 2024. We acknowledge your stated intent to discontinue production and distribution of 503B products effective January 31, 2025. As described below, the violations described in this letter are based on the observations in the most recent inspection and subsequent analysis, and they would continue to apply should you resume producing drug products intended to meet the conditions of section 503B.During the inspection, the investigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.A. Compounded Drug Products under the FD&C ActUnder section 503B(b) of the FD&C Act, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FD&C Act [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FD&C Act [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FD&C Act are met.2An outsourcing facility, which is defined in section 503B(d)(4) of the FD&C Act [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FD&C Act, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.B. Violations of the FD&C ActAdulterated Drug ProductsThe FDA investigators noted CGMP violations at your outsourcing facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The violations include, for example:1. 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)).2. Your firm failed to conduct laboratory testing to determine whether each batch of drug product purporting to be sterile conforms to such requirements (21 CFR 211.167(a)).3. 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).4. Laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy (21 CFR 211.194(a)(8)).5. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).6. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).7. Your firm failed to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release (21 CFR 211.165(d)).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FD&C Act. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance,Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s current thinking regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.C. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483. We acknowledge that your facility deregistered as an outsourcing facility on December 20, 2024.Some of your corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:Regarding your firm’s process validation for(b)(4)cycles used to(b)(4)sterilize Sodium Chloride Injection 0.9% USP in 500mL IV bags being performed using(b)(4)and not the drug product, you state that notwithstanding your discussion regarding this observation, “Exela understands the Agency’s position in raising this issue. If the 503B program continues, pending further discussions with the Agency, Exela intends to validate the(b)(4)cycles for 0.9% Sodium Chloride Injection, 1000 mL IV bags using the actual product. This will be supplemented by sterility testing at release.” We acknowledge this commitment to performing the validations and sterility testing. If you decide to produce drugs intended or expected to be sterile in accordance with 503B, you would be subject to CGMPs, including conducting process validations for all drug products prior to their production and distribution.Additionally, some of your corrective actions appear deficient:1. Your firm used(b)(4)media lot(b)(4)to release sterility testing of Sodium Acetate Injection (in vials). However, two tests of lot(b)(4)were invalidated and the third test was passed without scientific rationale. Your firm's investigation, QE-000487, states human performance was determined to be the root cause of the failed testing events. However, your firm did not document any specific human error identified when testing the(b)(4)media. Three other lots of test media ((b)(4)lot(b)(4),(b)(4)lot(b)(4), and(b)(4)lot(b)(4)) were documented in your firm's investigation, QE-000487, as failing initial GPT and passing retest, however, no root cause for these test failures were documented.In your responses, you state there was no impact to finished drug product since the observation resulted from human error rather than the media itself, however, you did not provide in your response evidence as to how you determined human error was the sole reason for the failed tests. In addition, your responses did not identify the source of the human error, or identify any improper techniques utilized by analyst(s) during the testing.2. You failed to perform contemporaneous two-person checks during the reading of environmental(b)(4)plates and subsequent data entry of the results in your(b)(4)software system. A single analyst reads environmental plate counts, takes pictures only of the positive counts, and then enters results in the(b)(4)software system. The Quality Control (QC) personnel later review and verify the results in the(b)(4)software system. There is no assurance the analyst read plate counts accurately or entered data in the software system accurately. On November 6, 2024, an FDA investigator observed miscounted plates with discrepancies when compared to the analyst’s count which were later corrected by the analyst.In your responses, you state that section 6.8.7.5 of your SOP-000189 “Use, Preparation, and Storage of QC – Microbiology Laboratory Media” has been revised. However, the revision does not clearly define when or how the second verifier will “…visually verify the presence or absence of microbiological growth….” Nor does the SOP address required timeframes as to when the second person will verify growth and ensure data is entered timely and correctly in the(b)(4)system. As written, the SOP fails to ensure contemporaneous QC review of plate counts and data accuracy.3. Regarding your failing to have stability data to support a six-month expiration date for Sodium Chloride 0.9%, USP packaged in 500 mL polypropylene IV bags from a batch size of(b)(4)produced on the “(b)(4)” line in the(b)(4)building, your firm was not adhering to your SOP-QA-000064, “Stability Policy and Guidelines for Establishing Expiration Date or Beyond Use Date of 503B Product.” Section 6.1.5, of the SOP, states stability protocols will be established, and studies will be conducted for variations of 503B products. Your response states you have discontinued the 503B program and are no longer 503B registered. If you decide to produce drugs in accordance with 503B, the establishment of stability protocols are expected to be completed and studies to be in process before producing and distributing finished drug product.We note that you refer to the “Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry, October 2024” in your response. It appears that your FDA 483 response may incorrectly describe some of the conditions discussed in this guidance. Should you resume production, in accordance with 503B, with the intent to qualify for the temporary policies described in this guidance, you should review it, particularly the conditions including using a default BUD of not more than 28 days at room temperature and not more than 42 days refrigerated when a sterility test has not been completed before release; the initiation of limited stability testing once the aggregate batch size of the product is expected to exceed 5,000 units; and initiation of CCIT with the first batch.4. Regarding your firm’s visual inspection program, you committed to developing improvements to your existing visual inspection program, however, no information was provided of what you will do in the meantime before all the corrections have been made, evaluated, and revised, if needed, along with training. In addition, we have the following concerns with your planned corrections:You state that your defect rates will be based on(b)(4)Visual Inspection of Medicinal Products for Parenteral Use standards. You did not provide any details explaining your rationale for using the(b)(4)or(b)(4)standards.Deficiencies on the risk assessment of your visual inspection program and process.i. Your risk assessment explains(b)(4)defects ((b)(4)) were not physically represented in the library of defects and concluded that they did not impact the integrity of the unit and, therefore, would have no impact on the patient. However, no information was provided as to why these(b)(4)defects would not impact the integrity of the unit or why the damaged(b)(4)was classified as a major defect rather than critical.ii. Your risk assessment stated, “From the risk ratings and review of other data, although the test sets did not include an example of each defect type identified in SOP-000266, this assessment provides confidence that the robust training program provided adequate training on the identification of defects through the training hours in conjunction with the visual aid of defects….” This assessment appears flawed as it is based on test sets not including an example of each defect type and based on(b)(4)data rather than data collected during the visual inspection phase.iii. It is not apparent if your risk assessment considered whether particulates could be inherent, intrinsic, or extrinsic in nature. It is not clear whether you have established defect(b)(4)with known inherent, intrinsic, or extrinsic defects for particulates. Therefore, it is not known whether visual inspectors can identify those defects during visual inspection. Furthermore, you are classifying all particulates as major defects, and your rationale for this classification is not provided.Your training or requalification time of(b)(4)periods does not reflect actual visual inspection conditions as documented in your batch record visual inspection worksheets.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FD&C Act. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b)]FDA strongly recommends that if you decide to resume compounding and distribution of sterile drugs your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.III. 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.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.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.If you decide to resume operations under section 503B of the FD&C Act, you should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.As part of your response, please verify in writing your continuing intention to not resume operations under section 503B of the FD&C Act. If you intend to resume such operations in the future, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. In addition to taking appropriate corrective actions, you should also notify us fifteen (15) working days prior to resuming production of drugs under section 503B of the FD&C Act in the future by contacting compoundinginspections@fda.hhs.gov.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3008563008 and ATTN: Erika V. Butler.We also recommend that, after you submit your response, you submit a Post-Warning Letter Meeting3request to: FDA-GDUFAIII-PostWarningLetterandReinspectionRequests@fda.hhs.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchF. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_____________________1See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.3Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans. Please see the Guidance for Industry “Post-Warning Letter Meetings Under GDUFA” for more information: https://www.fda.gov/media/171785/download

案件名称沈阳市佳艺义齿加工厂生产的定制式义齿标签、说明书与经注册相关内容不一致案处罚决定文书号辽药监(稽一)罚〔2025〕8号被处罚企业名称沈阳市佳艺义齿加工厂统一社会信用代码91210111683314788L法定代表人吴晓华主要违法事实当事人生产的定制式义齿标签、说明书与经注册相关内容不一致。行政处罚种类和依据罚款。 依据《医疗器械监督管理条例》第八十八条第二项。处罚结果处1万元罚款。行政处罚履行方式和期限主动履行；当事人已于2025年7月7日履行完毕。作出处罚的日期2025-07-03

当事人：天津博锐医疗器械有限公司主体资格证照名称：《营业执照》统一社会信用代码（注册号）：91120111MA06E1Y16R住所（住址）：天津西青学府工业区学府西路1号东区D2厂房B座202-2法定代表人（负责人、经营者）：李英新身份证件号码：XXXXXXXXXXXXXXXXXX 我局执法人员于2025年4月10日对天津博锐医疗器械有限公司开展现场检查，发现该公司生产的一类备案产品说明书中标识的产品性能与经备案的产品技术要求中的性能指标不一致。我局于2025年4月27日对当事人予以立案调查，2025年5月20日对当事人管理者代表进行询问调查。本案未对当事人实施行政强制措施。经查，当事人于2023年12月26日将产品技术要求中的性能指标“2.5吸水量”相关描述进行了变更，但产品说明书仍按备案变更前的内容表述。当事人的行为构成了生产说明书不符合规定的医疗器械的要件。上述事实，主要有以下证据证明：1.当事人提供的《营业执照》、《第一类医疗器械生产备案凭证》、《第一类医疗器械备案凭证》、《第一类医疗器械备案信息表》复印件各1份；2.法定代表人、授权委托人的身份证复印件及授权委托书各1份；3.现场笔录、询问笔录，变更前后的产品使用说明书、产品技术要求，批生产记录、检验报告单、成品检测记录、成品放行审批单、随货同行单、产品销售记录复印件各1份；4.当事人提供的主动召回信息发布，《医疗器械召回事件报告表》，《召回计划实施情况报告表》各1份；5.当事人提供的整改报告等证据材料。我局于2025年6月25日向当事人送达行政处罚告知书，当事人在法定期限内未提出陈述、申辩意见。本局认为，当事人生产说明书不符合规定的医疗器械的行为，违反了《医疗器械说明书和标签管理规定》第四条第二款“医疗器械说明书和标签的内容应当与经注册或者备案的相关内容一致。”和《医疗器械监督管理条例》第三十九条第一款“医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备案的相关内容一致，确保真实、准确。”的规定。依据《医疗器械监督管理条例》第八十八条第（二）项“有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：（二）生产、经营说明书、标签不符合本条例规定的医疗器械；”的规定，责令当事人改正违法行为，决定对当事人作出以下行政处罚：处罚款10000元。                天津市药品监督管理局                   （印章）                                          2025年07月07日

当事人：天津市百草厅医疗器械有限公司主体资格证照名称：《营业执照》统一社会信用代码（注册号）：911201113005043746住所（住址）：天津市西青区辛口镇泰华路2号院内7号厂房法定代表人（负责人、经营者）：李海芹身份证件号码：XXXXXXXXXXXXXXXXXX 我局执法人员根据举报于2025年4月18日对天津市百草厅医疗器械有限公司开展现场检查，发现该公司生产的一类备案产品砭贴说明书、标签标识的产品名称、型号规格、产品描述与经备案的相关内容不一致。我局于2025年4月27日对当事人予以立案调查，2025年5月13日对当事人总经理进行询问调查。本案未对当事人实施行政强制措施。经查，当事人分别于2023年12月13日和2024年09月26日申请了产品描述和型号规格的备案变更，但企业在备案变更后产品说明书、标签仍按备案变更前的内容标识。当事人的行为构成了生产说明书、标签不符合规定的医疗器械砭贴的要件。上述事实，主要有以下证据证明：1.当事人提供的《营业执照》、《第一类医疗器械生产备案凭证》、《第一类医疗器械备案凭证》以及《第一类医疗器械备案信息表》复印件各1份；2.法定代表人、授权委托人的身份证复印件及授权委托书各1份；3.现场笔录、询问笔录，批生产记录、成品检验报告单、销售出库复核清单复印件各1份；4.当事人提供的主动召回信息发布，《医疗器械召回事件报告表》，《召回计划实施情况报告表》各1份；5.当事人提供的整改报告等证据材料。我局于2025年6月25日向当事人送达行政处罚告知书，当事人在法定期限内未提出陈述、申辩意见。本局认为，当事人生产说明书、标签不符合规定的医疗器械砭贴的行为，违反了《医疗器械说明书和标签管理规定》第四条第二款“医疗器械说明书和标签的内容应当与经注册或者备案的相关内容一致。”和《医疗器械监督管理条例》第三十九条第一款“医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备案的相关内容一致，确保真实、准确。”的规定。依据《医疗器械监督管理条例》第八十八条第（二）项“有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：（二）生产、经营说明书、标签不符合本条例规定的医疗器械；”的规定，责令当事人改正违法行为，决定对当事人作出以下行政处罚：处罚款10000元。                天津市药品监督管理局                   （印章）                                           2025年07月07日

行政处罚信息摘要序号行政处罚决定书文号当事人名称法定代表人姓名违法事实行政处罚内容和法律依据作出行政处罚的行政机关名称和日期1新药监药处罚〔2025〕12号新疆药都药业有限公司张*燕质量管理体系不能正常运行，药品生产过程控制记录不真实，未遵守药品生产质量管理规范。依据《行政处罚法》第二十八条第二款，《药品管理法》第一百二十六条规定，结合国家药监局《药品监督管理行政处罚裁量适用规则》，经综合裁量，给予没收违法所得，罚款，责令停产停业整顿，没收企业负责人、质量负责人、生产负责人违法期间收入并处所获收入10%罚款的行政处罚。新疆维吾尔自治区药品监督管理局，2025年5月29日 附件下载： （此件于重新编辑） 相关链接：

行政处罚信息摘要序号行政处罚决定书文号当事人名称法定代表人姓名违法事实行政处罚内容和法律依据作出行政处罚的行政机关名称和日期1新药监药处罚〔2025〕11号新疆麦迪森药业有限公司饮片分公司黄*林质量管理体系不能正常运行，药品生产过程控制记录不真实，未遵守药品生产质量管理规范。依据《行政处罚法》第二十八条第二款，《药品管理法》第一百二十六条规定，结合国家药监局《药品监督管理行政处罚裁量适用规则》，经综合裁量，给予没收违法所得，罚款，责令停产停业整顿，没收企业负责人、质量负责人、生产负责人违法期间收入并处所获收入10%罚款的行政处罚。新疆维吾尔自治区药品监督管理局，2025年5月29日 附件下载： （此件于重新编辑） 相关链接：

行政相对人名称圣美伦（南京）香水有限公司行政相对人类别法人及非法人组织统一社会信用代码913201157360678309工商注册号组织机构代码税务登记号事业单位证书号社会组织登记证号法定代表人周信钢法定代表人证件类型身份证法定代表人证件号码3****************9证件类型证件号码行政处罚决定书文号苏药监宁处罚〔2025〕7号违法行为类型违反《化妆品监督管理条例》第三十条的规定。违法事实不按照强制性国家标准或者技术规范使用原料。处罚依据《化妆品监督管理条例》第六十条的规定。处罚类别罚款处罚内容处罚款10000元。罚款金额（万元）1没收违法所得没收非法财物的金额（万元）暂扣或吊销证照名称及编号处罚决定日期2025/07/07处罚有效期2026/01/06公示截止期2025/10/07处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。

行政相对人名称行政相对人类别行政相对人代码法人案件来源违法行为类型主要违法事实处罚依据处罚内容行政处罚决定书文号处罚决定日期处罚机关统一社会信用代码法定代表人1云南百渡园药业有限公司法人及非法人组织915300007755157201李志文其他部门移送销售劣药四味脾胃舒颗粒及未遵守药品经营质量管理规范案。当事人销售的劣药四味脾胃舒颗粒（批号：230780；生产单位：广西天天乐药业股份有限公司），经重庆市食品药品检验检测研究院检验，【含量测定】不符合规定。根据《中华人民共和国药品管理法》第九十八条第三款第一项规定，为劣药。办案人员检查当事人阴凉库不合格品区，未查见批号为230780四味脾胃舒颗粒3盒，当事人业务员李志光就私自将阴凉库不合格品区剩余的3盒四味脾胃舒颗粒自行服用，库管员及当事人对此均不知情。根据《中华人民共和国药品管理法》第一百一十七条、第一百二十六条、《中华人民共和国药品管理法实施条例》第七十五条及《中华人民共和国行政处罚法》第二十八条第一款的规定。1.警告；2.没收违法所得14187.03元。（云）药监药罚〔2025〕B16号2025年6月27日云南省药品监督管理局