FDA 483 - Bristol Myers Squibb Caribbean Company - April 18, 2007

An FDA inspection of Bristol Myers Squibb Caribbean Company in Mayaguez, PR, identified multiple deficiencies in their manufacturing of human parenteral drug products. The observations primarily concern inadequate controls for aseptic processing, including issues with sterilization validation, sterility testing procedures, and environmental controls. These findings indicate significant concerns regarding the firm's ability to prevent microbiological contamination and ensure the sterility of its drug products.