FDA Warns 2 Chinese API Manufacturers After Record Refusals, Expands Import Pressure On Compounding Supply

The FDA has sent warning letters to two Chinese active pharmaceutical ingredient manufacturers, Chongqing Qiancan Technology (CQT) and Tianjin Healthcare Medical Technology (THM), after both companies refused to provide records requested by the agency. According to the letters, the FDA concluded from import records that each company had imported multiple shipments of APIs into the U.S. intended for compounding.

The sequence matters because the companies did not avoid FDA jurisdiction simply by saying they would stop serving the U.S. market. THM told the agency on June 24 that it would discontinue production of the relevant products for the U.S. market and refused to provide the requested documents. The FDA repeated its request on June 25 and said the records were still required because THM's APIs had been imported into the U.S. market and were still within their expiration date. The agency said ceasing commercial distribution or expressing an intent to stop production did not retroactively relieve THM of its regulatory obligations.

The enforcement path

CQT took a different route but reached the same result. The company deregistered and discontinued its drug listing on June 29, then told the FDA the next day that it was unable to meet the agency's requirements. It never provided the requested records. On July 13, CQT reregistered with the FDA.

On Aug. 26, the FDA issued import alerts for all drugs and drug products that CQT and THM offer to ship to the U.S. Officials generally detain imported drugs made by companies subject to import alerts, and the policy of detaining imports without physical examination typically applies until the FDA completes an inspection. The agency invited both companies to schedule inspections.

As of now, the FDA said it is unable to confirm the companies' compliance with current good manufacturing practice and other applicable requirements. That has consequences beyond detained shipments: the agency said it may withhold approval of new applications or supplements that list the companies as manufacturers.

Why this matters for compounding supply

The notices indicate that record access itself is becoming a gating issue for API suppliers serving U.S. compounding. The FDA is not only policing product quality after an inspection; it is also signaling that refusal to provide documents can trigger import restrictions and complicate future filings tied to those manufacturers.

The agency published the notices alongside a warning letter to another Chinese company, Nanjing Hanxin Pharmaceutical Technology. Unlike CQT and THM, Nanjing Hanxin Pharmaceutical Technology provided the requested records, but the FDA said its review showed the company's quality unit failed to ensure its APIs complied with current good manufacturing practice. The agency also said the company's supplier oversight was deficient because its quality unit failed to adequately qualify companies providing critical raw materials, and noted a potential attempt to "circumvent safeguards." Its drugs are also subject to an import alert.