The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs).
As imports of pharmaceuticals from China and India have increased, so has FDA's enforcement of manufacturing for companies exporting to the US. In 2015, FDA carried out 132 inspections of Chinese manufacturers, more than twice the number it conducted in 2007.
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.
In the warning letter, FDA says 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.
Additionally, FDA says the Xiamen failed to respond to the deviations cited during the inspection, though the agency says the company managed to respond to the import alert on 14 June 2016.
Specifically, FDA cites Xiamen with three current good manufacturing practice (cGMP) violations and charges the company with attempting to mislead inspectors.
FDA says the company "repeatedly falsified and omitted information on the certificates of analysis (CoA) [it] issued to [its] customers." In one case, FDA says 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.
FDA also notes that 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 your facility."
In addition, 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.
As such, FDA says 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.
The agency also advises Xiamen to hire a consultant to help it address its manufacturing and quality management issues. "Based on the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations and assist your firm in meeting cGMP requirements," FDA writes.