FDA 向浙江兰溪 OTC 药品企业 Sanrace Biotechnology 发出警告信 320-27-09，指出三项 CGMP 违规

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Reference #:

320-27-09

Product:

Drugs
Over-the-Counter Drugs

Recipient:

Recipient Name

Mr. Qi-Lian He General Manager

Recipient Title

Mr. Qi-Lian He General Manager

Sanrace Biotechnology Co., Ltd.

268 Yanzhou Road
Lanxi Development Zone
Lanxi Shi
Jinhua Shi
Zhejiang Sheng, 321102
China

(b)(4)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 22, 2026

WARNING LETTER
Reference number: 320-27-09

To Mr. Qi-Lian He:

This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your records you 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, Sanrace Biotechnology Co., Ltd., FDA Establishment Identifier (FEI) 3016897521. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.

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 September 9, 2025 request and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.

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 (21 CFR 211.84(d)(1)).

Your firm manufactures OTC drug products including (b)(4). Based on the records and information you provided, you did not demonstrate that you adequately tested the identity of incoming components (e.g., (b)(4)) used in the manufacture of your drug products.

(b)(4)

You failed to adequately test your incoming (b)(4), used as an active ingredient in your drug products, 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).

(b)(4)

Identity testing for (b)(4) and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the components meet the relevant safety limits for levels of (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 these components for use in the manufacture of your drug products.

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).

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.

2. 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)).

Based on the records and information you provided, you did not demonstrate that your manufacturing processes are reproducible and controlled to yield a product of uniform character and quality. Specifically, your response states that your firm does not have process validation procedures or process validation studies.

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 of throughout each significant process stage to characterize intra-batch variation and evaluates 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 document 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.

3. 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)).

Based on the records and information you provided, 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:

• Adequate laboratory control procedures to ensure drug products conform to appropriate standards of identity, strength, quality and purity (21 CFR 211.160(b). Specifically, the records you provided demonstrate that you lack an adequate (b)(4) system monitoring program. The procedures you provided and (b)(4) test results lacked adequate testing for attributes such as (b)(4).
• The establishment of an adequate ongoing stability program (21 CFR 211.166(a)). For example, the records and information you provided lacked complete stability data and complete stability testing. Specifically, your records did not document viscosity, pH, assay, and microbiological testing to ensure that your drug products meet all quality attributes throughout their shelf-life.

Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download.

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 if your firm intends to resume manufacturing drugs for the U.S. market. 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.

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 September 21, 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 Sanrace Biotechnology Co., Ltd., 268 Yanzhou Road, Lanxi Development Zone Lanxi, Jinhua, Zhejiang Province, 321102 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, 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 15 business days of receipt of this letter. Identify your written response with FEI 3016897521 and ATTN: Daniel W. Brisker 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: Registered US Agent:
Mr. Manoj Zacharias
Liberty Management Group Ltd.
(b)(4)