FDA issues warning letter after Chinese firm impedes investigation
pharmafile | November 2, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | China, FDA
The US Food and Drugs Administration (FDA) has issued a Chinese firm with a warning letter after claims it intentionally impeded an inspection of its facility in November 2015.
Active pharmaceutical ingredient (API) maker Beijing Taiyang Pharmaceutical Industry Company has been accused of shady behaviour which made it impossible for the FDA to carry out a proper inspection; the Chinese firm allegedly denied access to and later hid large quantities of suspicious barrels branded with its label.
“On November 16, 2015, our investigators observed through a window a warehouse containing numerous drums bearing your company’s label,” the FDA’s warning letter reads. “When our investigators requested access to this warehouse, you barred them from entering the warehouse to examine the containers or the material in them without giving a reasonable explanation.
“When [investigators] asked about the drums they had observed the previous day, you provided no explanation of the whereabouts or contents of the drums. You delayed FDA’s access to the warehouse and limited FDA’s inspection by removing the drums before our investigators could inspect them.”
The API maker is also accused of inadequate data-archival related to manufacturing & laboratory control and quality-related activities, with the FDA deeming that its systems do not “adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”
The agency has advised the Chinese firm to seek a third-party consultant to rectify the issues outlined in its warning.
Matt Fellows
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