FDA 483 - Lotte Biologics USA, LLC - June 05, 2019

An FDA inspection of Bristol-Myers Squibb Co., Pharmaceutical Research Institute in East Syracuse, NY, from May 28 to June 5, 2019, revealed a significant failure in their quality control processes. The firm did not thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, OOS results were invalidated, and passing retest results were reported without identifying scientifically sound and justifiable root causes.