FDA EIR - Bristol-Myers Squibb Company - August 14, 2006

An FDA surveillance inspection was conducted at Bristol-Myers Squibb Co., Pharmaceutical Research Institute in East Syracuse, NY, from August 2 to August 14, 2006. The inspection's primary objective was to evaluate compliance with Good Laboratory Practice (GLP) regulations for non-clinical laboratories, guided by regulatory framework CP 7348.808. During the assessment, the FDA did not issue any formal inspectional observations. However, one minor procedural deficiency was identified and discussed with company management. This issue concerned the facility's failure to follow its established written procedures for reporting a protocol deviation. Specifically, a "Deviation from Protocol" form was not prepared or submitted when a test article and a control article batch for a study were improperly stored without a desiccant. Although the deviation was reported to the study director and documented in the final report, the formal internal reporting process was not fully adhered to. In response to this observation, Bristol-Myers Squibb's management updated their written procedures to provide clear, detailed instructions for future protocol deviation reporting. The company also confirmed that issues noted during previous inspections had been corrected and reiterated its commitment to regulatory compliance. The inspection concluded with a "No Action Indicated" classification, indicating that no further formal regulatory actions were deemed necessary by the FDA at that time, acknowledging the minor nature of the finding and the company's proactive resolution.