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Warning letter issued to Chinese drug manufacturer Xiamen Origin Biotech over cGMP violations

The US Food and Drug Administration (FDA) has issued a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs). The deviations were discovered during a three-day inspection of Xiamen's Fujian facility in January, which resulted in FDA issuing an import alert for the company's products in May.

According to the warning letter, the facility lacked written procedures for its quality management system, issued falsified records to its customers and failed to keep clean warehouses used to store its APIs. Specifically, FDA cites Xiamen with three current good manufacturing practice (cGMP) violations and charges the company with attempting to mislead inspectors as mentioned below:

• The company "repeatedly falsified and omitted information on the certificates of analysis (CoA) which it issued to its customers." In one case, FDA observed that the company used a fake employee name and signature on CoAs it sent out, and used an expiration date on the CoA "that exceeded the manufacturer's labeled expiration date" without any basis for doing so.
• Xiamen failed to keep its facilities clean: "During the inspection, the investigator recorded dirty warehouse spaces and observed a rodent in the room adjacent to the warehouse at its facility."
• One Xiamen employee tried to mislead FDA inspectors by telling them that "there were no drugs on site," and that the company had stopped relabeling drugs in January 2015, despite records indicating the company continued to distribute drugs into January 2016.

According to FDA, it may withhold approval of new applications and supplements that cite Xiamen as an API manufacturer and will continue to refuse imports of drugs manufactured by the company until the issues cited in the letter are addressed. FDA has also advised the company to hire a consultant to help it address its manufacturing and quality management issues.


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