FDAnews Drug Daily Bulletin

Chinese API Manufacturer Cited for Quality Shortcomings

July 12, 2018

The FDA issued a warning letter to Zhuhai United Laboratories, an active pharmaceutical ingredient firm based in Zhuhai, China, taking the facility to task for failure to investigate out-of-specification results and correct critical CGMP deviations.

In a Sept. 11-15, 2017 inspection, the agency found the company did not have adequate procedures for investigating and invalidating OOS results.  After looking into an OOS assay result for a batch that was found to be well below specification, the firm found no anomalies and only noted the possibility of sample glassware not being thoroughly cleaned.

“Your acceptance of the passing results on an assumed laboratory error was insufficient to invalidate the original failing result,” the agency said.

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