FDAnews Drug Daily Bulletin

Warning Letter Faults Chinese Firm for Data Mishandling

Aug. 9, 2016

The FDA has faulted an API maker for a host of failings at its production facility in China, including tampering with official records.

The FDA cited Xiamen Origin for three primary deficiencies found at its Fujian facility during an inspection in January: its mishandling of records, its failure to adhere to GMP and unsanitary conditions at the plant.

Chief among the issues raised in the agency’s warning letter were instances of plant officials repeatedly falsifying and omitting information from the certificates of analysis issued to customers. Inspectors noted that the altered certificates did not include information about the original API and included an expiration date that exceeded the manufacturer’s labeled expiration date.

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