Tianjin Healthcare Medical Technology Co., Ltd.

October 29, 2026
 

WARNING LETTER
Reference number: 320-27-15

To Jianyu Zhao:

This warning letter advises you of a significant violation identified during a U.S. Food and Drug Administration (FDA) review of records from your facility and provides you the opportunity to address them. This is not intended to be an all-inclusive list of violations. 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.

Your facility, Tianjin Healthcare Medical Technology Co., Ltd. (hereafter THM), FDA Establishment Identifier (FEI) # 3015495180 at 2-2066, No 88 HuanHe South Road, Tianjin Free Trade Pilot Zone, KongGang Economic Zone, Tianjin is registered with the FDA as a manufacturer of active pharmaceutical ingredients (APIs).

A review of import records showed multiple shipments of APIs intended for pharmacy compounding into the U.S., which declared THM, as the drug manufacturer. The FDA sent requests for records and other information, pursuant to section 704(a)(4) of the Federal Food, Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact email address provided in your registration file. Your firm refused to provide the duly requested records.

It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a). Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs listed as manufactured at your facility.

Refusal to Provide Records

On June 17, 2026, the FDA sent an electronic records request to the contact email address provided in your registration file. You replied on June 24, 2026, that you would “discontinue the production of relevant (b)(4) products” for the U.S. market and refused to provide the requested documents. A follow up request was sent on June 25, 2026, informing you that APIs your firm manufactured were imported to the U.S. market and were still within expiry. Therefore, the requested records were still required. You responded that you would not provide the requested records.

Simply ceasing commercial distribution or expressing an intent to stop production does not retroactively relieve you of your regulatory obligations.

FDA placed all drugs and drug products offered for import into the U.S. from your firm on Import Alert 66-79 on August 25, 2026.

If you no longer intend to manufacture or distribute drug products for the U.S. market, you must formally update your registration and drug listings to reflect this change in operations. Pursuant to 21 CFR 207.29(a)(3), an establishment must update its registration within 30 calendar days of ceasing operations.

Conclusion

The violation cited in this letter is not intended to be an all-inclusive list of violations at your facility.

Until FDA is able to confirm compliance with CGMP and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at THM, 2-2066, No 88 HuanHe South Road, Tianjin Free Trade Pilot Zone, KongGang Economic Zone, Tianjin into the U.S. that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).

In response to this letter, you may submit a request to schedule an FDA inspection.

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 3015495180 and ATTN: Marva Taylor in the letter 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: U.S. agent
(b)(6)