Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.

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October 27, 2026

WARNING LETTER
Reference number: 320-27-13

To Mr. Yun Ma:

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 and provides you an opportunity to address them. Promptly address any 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 in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory action without further notice.

FDA Review

Violations were identified and documented during review of your drug manufacturing facility, Guangzhou Jiugong Research And Development Biotechnology Co., Ltd., FDA Establishment Identifier (FEI) 3043646847. 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 FDA as a manufacturer of over-the-counter (OTC) drug products, including (b)(4). FDA has reviewed the records submitted from (b)(4) on your behalf in response to our May 1, 2026, request 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 FD&C Act (21 U.S.C. 351(a)(2)(B)).

Additionally, the OTC drug product, “(b)(4),” is adulterated under section 501(a)(4)(A) as this drug product bears or contains a color additive that is unsafe within the meaning of section 721 of the FD&C Act, 21 U.S.C. 379e. Accordingly, the introduction or delivery for introduction of “(b)(4)” into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

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.

Use of Cancelled Color Additive FD&C Red No. 2

Based on our review of drug product labels, the “(b)(4)” contains the color additive “CI 16185” (also known as FD&C Red No. 2 or Amaranth). In 1976, FDA cancelled the certification and delisted FD&C Red No. 2 because it could not be proven safe for use. Under 21 CFR 81.30(j)(1), using FD&C Red No. 2 in drugs after January 28, 1976, results in the drug being adulterated.

Any color additive not explicitly listed as safe for its intended use is deemed unsafe within the meaning of section 721(a) of the FD&C Act. The inclusion of a delisted color additive in your drug product formulation indicates that your quality unit’s review (as required under 21 CFR 211.22) of your raw material qualification process and formulation review procedures is inadequate.

Your firm’s quality 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).

The records and information provided demonstrate that the quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of the drug manufacturing operations. The response includes discrepancies between the color additive on the labeling versus the batch formulation spreadsheet versus the color specified in the certificate of analysis (COA). For example, the labeling for the “(b)(4)” listed “CI 16185” (also known as the cancelled color FD&C Red No. 2) as the color additive. However, the separate formulation ingredient information provided listed a second color additive (b)(4) (also known as (b)(4)) and the COA provided indicated a third distinct color additive, (b)(4).

On July 28, 2026, the FDA sent an electronic request for additional information requesting clarification of these color additive discrepancies. This request went unanswered as did the follow-up electronic request sent on August 5, 2026.

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, the following:
  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.
• A comprehensive assessment of your documentation to ensure you retain accurate records throughout your operation.
• A list of all products distributed in the United States in the last three years, with lot number, quantity shipped, and expiry dates. Identify the drug products you distributed.
• A list of your customers and addresses where the drug products were distributed.
• A copy of your quality agreement with the product owner, (b)(4).
• A risk assessment to review all your drug formulations to ensure the use of appropriate color additives, including any that may use alternate names. For more information, see the webpage for Regulatory Status of Color Additives at https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives.
• Your action plan to address any product quality or patient safety risks for batches of (b)(4) in U.S. distribution, including customer notifications and recalls or market withdrawals.

Responsibilities as a Contractor

You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

Revocation of FD&C Red No. 3

FDA revoked the authorization for the use of FD&C Red No. 3. We recommend manufacturers review their drug product formulations. Manufacturers who use FD&C Red No. 3 in ingested drugs will have until January 18, 2028, to reformulate their products. For more information, see https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs.

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 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 refusing admission of articles manufactured at Guangzhou Jiugong Research And Development Biotechnology Co., Ltd., located at No. 3 Yiheng Road, Nanling Gongye Districtqinghu Ma Tian Street, Jiahe Street, Baiyun District, Guangzhou, Guangdong 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 CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3043646847 and ATTN: Lynnsey Renn 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:
FDA Listing
US agent
(b)(4)