FDA 483 - Bausch & Lomb Incorporated - May 26, 2017

The FDA inspection of Bausch & Lomb, Inc. in Tampa, FL, revealed significant deficiencies across multiple systems, including production, facilities, quality, and laboratory controls. Key issues included the release of drug products potentially contaminated with Burkholderia cepacia, inadequate aseptic processing controls, and failures in complaint handling and investigations. These findings indicate a systemic lack of adherence to cGMP requirements, posing potential risks to drug product quality and patient safety.