FDA warns Chinese API manufacturers for refusing records requests, quality oversight
The US Food and Drug Administration (FDA) recently issued warning letters to three manufacturers of active pharmaceutical ingredients (APIs) based in China. Two of the companies were warned for refusing to comply with the FDA's requests for records, while the third was cited for lacking appropriate quality oversight of the raw ingredients.
All three warning letters were posted on 10 November. The products in question were intended for pharmaceutical compounding within the US. As a result, products from all three companies have been placed under an import alert.
Tianjin Healthcare
FDA issued a warning letter to Tianjin Healthcare Medical Technology Co., Ltd. in Tianjin, China, after the company failed to respond to two requests for electronic records. This action was initiated following FDA’s review of import records indicating that multiple shipments of APIs were intended for pharmacy compounding into the US.
The first request for records was sent on 17 June 2026. In its response on 24 June, the company declined to provide the requested documents and stated that it would cease production of these products for the US market.
A follow-up request for records was sent on 25 June 2026, in which FDA informed the company that the APIs it manufactured were still being imported to the US market and were still within their expiration dates. The company reiterated its refusal to provide the requested documents.
FDA emphasized that “simply ceasing commercial distribution or expressing an intent to stop production does not retroactively relieve you of your regulatory obligations.”
Chongqing Qiancan Technology Co., Ltd.
A similar scenario was noted in the warning letter sent to Chongqing Qiancan Technology Co. in Chongqing Shi, China. Through a review of import records, it was discovered that the company was shipping APIs intended for prescription compounding into the US.
On 17 June, FDA requested records from the company; however, it refused to provide the requested information. Instead, the company deregistered and discontinued the drug listing on 29 June. The following day, it stated that it could not meet FDA requirements. Nevertheless, the company re-registered two weeks later.
Nanjing Hanxin Pharmaceutical Technology Co. Ltd.
Unlike the previous two companies, Nanjing Hanxin Pharmaceutical Technology Co. Ltd in Jiangsu Sheng, China, complied with FDA’s records request. Despite complying, the company received a warning letter citing it for good manufacturing practice (GMP) violations.
FDA stated that the company's quality unit failed to fulfill its responsibility to ensure that the APIs produced at the site complied with GMPs. FDA noted that the quality unit did not adequately qualify its critical raw materials supplier.
Following this, the agency inspected the supplier and concluded that the drugs manufactured at the site were adulterated. This was due to the supplier's manufacturing methods, facilities, and controls for manufacturing were not conforming to GMPs.
Tianjian, Chongqing Qiancan, Nanjing Hanxin
