Chinese API Manufacturer Cited for Quality Shortcomings

July 13, 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.

The FDA called for the company to conduct a retrospective review of all invalidated OOS results obtained for its products on the U.S. market. It also requested an evaluation of all instances where a statistical outlier test was used to invalidate OOS results and an assessment of the potential effect on drug quality.

In addition, the facility’s quality unit failed to adequately investigate findings from a retrospective review of analytical chromatography data irregularities, as it did not sufficiently expand the scope of its review to a larger data set when significant data integrity lapses were discovered.

The agency requested a copy of the deviation investigation initiated in response to the inspection findings.

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