FDA determines Xiamen Origin Biotech wilfully lied to inspectors and customers
pharmafile | August 4, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | FDA, Xiamen Origin Biotech
The US Food and Drug Administration (FDA) carried out an inspection of Chinese drug manufacturer Xiamen Origin Biotech, finding the facilities to deviate from ‘current good manufacturing practice (CGMP) for active pharmaceutical ingredients.
Among the numerous problems the organisation highlighted, it was noted that the manufacturer had no satisfactory system to record and manage quality, with no written procedures for supplier qualification, relabelling operations, sampling, product release, document retention or training.
The company failed subsequently failed to adequately communicate all quality and regulatory data to its customers, omitting and even falsifying information on certificates of analysis (COA) it issued. The company went as far as to fabricate the name of an employee as the authority on these COAs. Employees were also witnessed providing wilfully misleading information to impede the investigator.
Perhaps most strikingly, the regulatory body also found the facility to be below hygiene standards, observing dirty warehousing spaces and rodent activity.
The FDA has issued an ultimatum of 15 days to enact corrective actions, reserving the right to withhold approval or admission of products manufactured at the facility until the company complies with CGMP standards.
Matt Fellows
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