FDA 483 - Yuki Gosei Kogyo Co., Ltd. - November 17, 2017

During an FDA inspection, significant deviations from laboratory control procedures and quality system requirements were identified. The facility failed to follow written laboratory control procedures, specifically regarding electronic chromatography data. Original or processed injections were not reported, and no investigations were initiated for deviations or out-of-specification results, as required by SOP JHA405 and JHA419. Trial sample analyses were performed but not reported in official QC analytical batch records.

Records for drug substance production were not readily available for inspection. During a walk-through, personnel were observed attempting to conceal records and materials. Approximately 4 plastic bags of documents and 5 bins of reagents/samples were found in a meeting/break room, which analysts admitted were hidden due to disorganization.

Supervisory oversight of laboratory electronic systems and data was deficient. No data integrity program was in place for a statistically sound review of electronic data (network and standalone) to ensure completeness, consistency, and accuracy of chromatographic raw data. A QC electronic review procedure for analytical test data was only recently implemented, and no retrospective review of electronic data had been performed.

The Quality Unit lacked adequate control over expired laboratory reagents, samples, and finished batches. Approximately 25 uncontrolled expired reagents, 11 unopened reagents, and 17 samples were found in the meeting/break room. Two unidentified drums, later identified as containing drug substance lots from 2013 and 2014, were found without proper labeling.

GMP