FDA Warns Chinese Drug Manufacturer Xiamen

Source: Regulatory Affairs Professional Society

Aug 03, 2016

The U.S. Food and Drug Administration (FDA) sent 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.

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.

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. Specifically, FDA cites Xiamen with three current good manufacturing practice (cGMP) violations and charges the company with attempting to mislead inspectors.

Read the full articleRead the full FDA lettter

 

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