Chongqing Qiancan Technology Co., Ltd.

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, Chongqing Qiancan Technology Co., Ltd. (hereafter CQT), FDA Establishment Identifier (FEI) # 3040333997 at 9-13, No. 8 Auxiliary, No. 505, Shangmao M. Road, Duzhou SubDistrict, Changshou District, Chongqing is registered with the FDA as a manufacturer of active pharmaceutical ingredients (APIs).

A review of import records showed multiple shipments of API intended for prescription compounding into the U.S., which declared CQT 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 having been manufactured at your facility.

On June 17, 2026, FDA sent an electronic records request to the contact email address on file in your registration. Your firm de-registered and discontinued your drug listing on June 29, 2026, one day prior to your reply on June 30, 2026, in which you stated that your firm was unable to meet FDA requirements. The requested records were never provided despite APIs manufactured by your firm being imported to the U.S. market and still being within expiry.

Notably, your firm re-registered on July 13, 2026.

It is your responsibility to ensure the drugs you manufacture meet U.S. standards prior to distributing them into the U.S. supply chain.

FDA placed all drugs and drug products offered for import into the U.S. from your firm on Import Alert 66-79 on August 26, 2026.

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 your compliance with Current Good Manufacturing Practice 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 CQT, located at 9-13, No. 8 Auxiliary, No. 505, Shangmao M. Road, Duzhou SubDistrict, Changshou District, Chongqing coming 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.

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.