FDA EIR - Lotte Biologics USA, LLC - March 29, 2002

An FDA Good Laboratory Practice (GLP) surveillance inspection was conducted at Bristol-Myers Squibb Co Pharm in Syracuse, NY, from March 19 to March 29, 2002. This routine inspection, performed under a specific compliance program for non-clinical laboratories, aimed to assess the facility's adherence to GLP regulations. During the inspection, several observations were noted and documented on an FDA-483 form. These included a deficiency in specimen labeling, two deficiencies related to standard operating procedures (SOPs) for specimen labeling, and one record-keeping deficiency concerning cage washer evaluations. The report specifically stated that these observations did not compromise the integrity of the studies performed at the facility. In response to the findings, Bristol-Myers Squibb management promptly initiated corrective actions. A written response addressing the inspectional findings was submitted to the FDA on April 15, 2002. The overall inspection was categorized as "Voluntary Action Indicated," signifying that although some issues were identified, the firm's proactive measures were deemed sufficient, and formal regulatory enforcement was not required.