FDA EIR - Lotte Biologics USA, LLC - June 16, 2004

The FDA conducted a Good Laboratory Practice (GLP) surveillance inspection of Bristol-Myers Squibb Co., Pharmaceutical Research Institute in Syracuse, NY, from June 7-16, 2004. This routine inspection, guided by regulatory frameworks such as CP 7348.808 for non-clinical laboratories and 21 CFR Part 58 for human drug studies, aimed to assess compliance. While no FDA-483 Inspectional Observations were issued, three minor deficiencies were discussed with management. These included the failure to consistently document weekly inspections of the animal bedding storage area, and an isolated instance of incorrect labeling on a box of clinical pathology slides, which was immediately rectified. Additionally, a recurring observation from a previous review highlighted the absence of explicit statements in study protocols ensuring Study Directors are formally informed of test and control article stability testing results and characterization evidence for inclusion in final reports, despite internal SOPs addressing this. Management acknowledged these findings. They promised to implement corrective actions for documenting animal bedding storage area inspections and are considering incorporating the protocol statement recommendation at a corporate level to enhance procedural harmonization. The report also noted an internal SOP deviation where animals for a study were randomized before the minimum quarantine period was fully met. While this was addressed internally by the firm through SOP revisions, the FDA recommended a consistent "hands-off" approach during animal acclimation and harmonization of related SOPs. Another recommendation involved adding specific instructions to an SOP for saving electronic animal assignment records in their new data collection system.