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

An FDA inspection of Bausch & Lomb, Inc., a division of Valeant Pharmaceuticals, in Tampa, FL, occurred from May 15 to May 26, 2017. This comprehensive review assessed Current Good Manufacturing Practices (cGMP) and pre-approval processes for several new drug applications, adhering to regulatory frameworks CP 7356.002 and CP 7346.832, and scrutinizing quality, laboratory, production, and facility systems. Numerous significant violations were identified and documented in an FDA Form 483. These included the Quality Unit's release of nasal drug products potentially contaminated with *Burkholderia cepacia*. Deficiencies were also noted in sterile process simulations, with inadequate unit accountability and rejection justifications during media fills. The environmental monitoring system in aseptic processing areas was found to be insufficient, lacking complete continuous non-viable particle monitoring, proper passive air monitoring, and representative personnel monitoring. Other critical issues involved a failure to determine actual yields, inadequate cleaning and disinfection controls for aseptic areas, and a lack of investigation into HEPA filter stains. Complaint investigations and general root cause analyses were consistently deficient in documentation, evidence, and timely justification. Furthermore, laboratory controls lacked scientifically sound test procedures, and deviations from written procedures were not adequately recorded or justified. Due to these findings, the FDA recommended a "withhold" for the pending drug applications. Bausch & Lomb's management was instructed to respond to the observations within 15 business days, emphasizing their responsibility to achieve full compliance to avert further regulatory actions.