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Pharmaceuticals / Inspections and Audits

FDA Warns Korean Firm for Inadequate Quality Controls, Testing

June 8, 2018

The FDA blasted Kolmar Korea for failures to investigate out-of-specification test results and to follow standard operating procedures after a September inspection of its Sejong City facility.

The agency found that the company did not investigate out-of-specification assay test results for three lots of its over-the-counter cream product, finding that it retested the samples, invalidated the OOS results without any scientific justification and released the lots into the U.S. market.

The firm said its analysts had failed to follow OOS checklist procedures and it promised to retrain them and review the checklist. The agency said this response was inadequate because the investigation did not include a retrospective evaluation of all invalidated OOS results that lacked a scientific backing.

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