FDA 向浙江高荣化妆品发出警告信 320-27-01，指成分鉴别检测与质量部门职责违反 CGMP

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Reference #:

320-27-01

Product:

Drugs
Over-the-Counter Drugs

Recipient:

Recipient Name

Ms. Yunji (Lucy) Gao

Recipient Title

Facility Contact

Zhejiang Gaorong Cosmetic Co., Ltd.

No. 88 Xixi Street
Linjiang Industrial Park
Jinhua Shi
Zhejiang Sheng, 321204
China

[email protected]

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 1, 2026

WARNING LETTER
Reference number: 320-27-01

To Ms. Yunji (Lucy) Gao:

This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of records submitted from your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice.

FDA Review

Violations were identified and documented during review of your drug manufacturing facility, Zhejiang Gaorong Cosmetic Co., Ltd., FDA Establishment Identifier (FEI) 3009819718. This review was conducted under the FDA’s statutory authority and public health responsibilities to product the public from unsafe, ineffective, and poor quality drugs.

Your facility is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our January 20, 2026, request and subsequent correspondence for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)).

Violations of the Federal Food, Drug, and Cosmetic Act

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations at your facility.

1. 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)).

Your firm manufactures OTC drug products, such as (b)(4). Based on the records and information you provided, you did not demonstrate that you tested each shipment of each lot of incoming components adequately before their use in manufacturing. For example, the documentation provided did not include adequate identity and impurities testing for (b)(4), a component at risk for (b)(4) contamination, or adequate identity and impurities testing for (b)(4), a component at high risk for (b)(4) contamination. Your firm also relied on the supplier’s certificate of analysis (COA) and accepted the active pharmaceutical ingredients (API) based on your supplier’s COA without establishing the reliability of your supplier’s test analyses at appropriate intervals.

Without adequate testing and confirmation of the reliability of supplier test results, you lack scientific evidence that the components or drug products conform to the appropriate specifications before its use in the drug products you manufacture.

The use of ingredients contaminated with (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) contamination at (b)(4)

You manufacture drugs that contain (b)(4). (b)(4) substitution in (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4)

In response to this letter, provide:

• 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 and periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
• A summary of your program for qualifying and overseeing the contract facilities that test the components and drug products you manufacture.
• A commitment to provide (b)(4) test results from testing retains for all lots of high-risk drug components used in the manufacture of drug products, no later than 30 calendar days from the date of this letter. 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).
• A full risk assessment for drug products that are within expiry containing any ingredient at risk for (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), 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.
• 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.

2. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

The records and information you provided demonstrate that your quality unit (QU) did not exercise its responsibilities to oversee the quality of your drug-manufacturing operations effectively. For example, your QU failed to ensure appropriate batch-production records with complete details. Your QU also failed to ensure that adequate stability data supported the expiry of your drug products.

Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations.

In response to this letter, provide:

• A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
  o A determination of whether procedures used by your firm are robust and appropriate.
  o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
  o A complete and final review of each batch and its related information before the QU disposition decision.
  o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all 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 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. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download.

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 States

In 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.

Conclusion

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on July 31, 2026.

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 Gaorong Cosmetic Co., Ltd., No. 88 Xixi Street, Linjiang Industrial Park, Jinhua, Zhejiang, 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 [or misbranded] may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

Send your written response to [email protected] within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3009819718 and ATTN: Zachary Bogorad in the letter or /in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

FDA posts warning letters to www.FDA.gov.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

cc: Medright Tech Inc.
U.S. Agent
[email protected]