Pharmaceutical

FDA barred from inspecting China drug manufacturing company

china 435x275 FDA barred from inspecting China drug manufacturing company Last November, Food and Drug Administration (FDA) investigators peeped into the windows of a warehouse at Beijing Taiyang Pharmaceutical Industry Co. Ltd., in China and spotted numerous drums bearing the company’s label. But when investigators asked to access the warehouse, employees “barred them from entering … without a reasonable explanation.”

The following day, the company gave the investigators access to the warehouse. “However, upon entry they spotted that a number of the drums had been removed and were not available for inspection. When they asked about the drums they had observed the previous day, (employees) provided no explanation of the whereabouts or contents of the drums.”

For this, and several other issues including alleged “systematic data manipulation” throughout the facility, the company received an FDA warning letter asking for a response within 15 working letter detailing specifically what the company has done to correct the deviations and to prevent their recurrence.

The agency also called out Beijing Taiyang Pharmaceutical Industry for faking and manipulating test results to support batch release and stability data and routinely re-tested high performance liquid chromatography samples and deleted previous chromatograms without justification.

The company was placed on Import Alert and until all deviations are completely corrected and the agency confirms its compliance with current Good Manufacturing Practices, the FDA may withhold approval of any new applications or supplements for drug products listing the company as a drug manufacturer.

Sources:
FDA
Law360