WARNING LETTER
Zhejiang Qimei Cosmetics Co., Ltd.
MARCS-CMS 690950 —
November 07, 2024
Delivery Method:
VIA UPS
Reference #:
320-25-13
Product:
Drugs
Recipient:
Recipient Name
Mr. Jinyan Wang
Recipient Title
General Manager
Zhejiang Qimei Cosmetics Co., Ltd.
No. 518 ChuangYe Road
Chongfu Town
Tongxiang Shi
Jiaxing Shi
Zhejiang Sheng
,
314511
China
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-25-13
November 7, 2024
Dear Mr. Wang:
Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 11, 2024 request, and subsequent requests, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Zhejiang Qimei Cosmetics Co., Ltd., FEI 3018321301, located at No. 518 ChuangYe Road, Chongfu Town, TongXiang City, Jiaxing, Zhejiang 314511, China.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your responses to our 704(a)(4) requests do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).
Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:
1. Your firm’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 manufactured over-the-counter (OTC) isopropyl alcohol (IPA) prep pad drug products, labeled as sterile, that are intended as an antiseptic for preparation of the skin prior to an injection. Based on the records and information you provided, you did not demonstrate that your quality unit (QU) effectively exercised its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU did not adequately exercise its authority to ensure that your OTC IPA prep pad drug products, that are labeled as sterile, are rendered sterile by an appropriate manufacturing process. For example, your responses did not demonstrate that your manufacturing processes are adequate to render your product sterile.
Your QU is responsible for fully exercising its authority and responsibilities, including responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. See FDA’s guidance document
Quality Systems Approach to Pharmaceutical CGMP Regulations
for 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.
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 (21 CFR 211.165(a)).
Based on the records and information you provided, you did not demonstrate that you adequately tested your OTC IPA prep pad drug product for the identity and strength of the active ingredient, IPA, prior to release and distribution. For example, your August 26, 2024 response included only a chemical safety data sheet for IPA and a supplier’s certificate of analysis (COA) for IPA, and does not demonstrate that your firm performed testing for the identity and strength of the IPA active ingredient in your finished drug product.
Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution. Without adequate testing, you do not have scientific evidence to assure that your drug products conform to appropriate specifications before release.
3. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. (21 CFR 211.84(d)(1)).
Based on the records and information you provided, you did not demonstrate that you adequately tested the identity of your incoming components including glycerin, propylene glycol, ethanol, and IPA that are used in the manufacture of your OTC drug products. For example, your May 6, 2024 response states that your firm does not perform diethylene glycol/ethylene glycol limit testing for your glycerin and propylene glycol components, or methanol limit testing for your ethanol and IPA components.
Identity testing for glycerin and propylene glycol and certain other high-risk drug components include 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 identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.
Glycerin
The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
to 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.
Ethanol and Isopropyl Alcohol
You also failed to adequately test your incoming ethanol and IPA, used as active ingredients, for methanol. The use of ethanol and IPA contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/173005/download.
Without adequate testing, you do not have scientific evidence that your components conform to appropriate specifications prior to use in the manufacture of your drug products.
CGMP Consultant Recommended
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.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
FDA placed your firm on Import Alert 66-40 on November 7, 2024.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Zhejiang Qimei Cosmetics Co., Ltd., 3018321301, at No. 518 ChuangYe Road, Chongfu Town, TongXiang City, Jiaxing, Zhejiang 314511, China, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission.
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 3018321301 and ATTN: Joel Hustedt.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
CC:
Registered U.S. Agent
T-W Serv Inc.
Ms. Christina Wong
Email: service18312@outlook.com
Content current as of:
11/12/2024
Regulated Product(s)
Drugs