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.
The company also did not ensure its staff followed a standard operating procedure for document control, which requires quality unit approval before throwing out document and records. Documents such as batch production records, laboratory worksheets and certificates of analysis were found torn and discarded without approval of the quality unit.
Kolmar acknowledged that its personnel were not properly trained in CGMP-compliant document handling procedures and vowed to discontinue the poor practices, train employees and revise its procedures. The FDA also found this response inadequate, as the firm did not address its training program’s effectiveness or specific actions it will take to enforce written procedures.
The agency requested a detailed plan for evaluating the effectiveness of its training program and a complete assessment of the documentation systems used in manufacturing and laboratory operations to identify inadequate documentation practices.