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

An FDA inspection of Bausch & Lomb, Inc., a division of Valeant Pharmaceuticals, was conducted at its Tampa, FL facility from May 15 to May 26, 2017. This comprehensive inspection covered current Good Manufacturing Practices (cGMP) and pre-approval requirements for multiple New Drug Applications (NDAs) related to ophthalmic, nasal, and otic products. The inspection, performed under FDA’s drug manufacturing and pre-approval guidelines, revealed significant deficiencies, resulting in the issuance of an FDA Form 483.

Key violations included the Quality Unit's release of nasal drug products potentially contaminated with the objectionable organism Burkholderia cepacia, and inadequacies in sterile process simulations like media fills and unit accountability. Environmental monitoring in aseptic processing areas was deficient, specifically regarding the installation of continuous non-viable particle monitoring devices in critical filling lines and inconsistent passive air monitoring in intervention areas. Furthermore, the Quality Unit failed to implement adequate cleaning and disinfection controls for aseptic areas and did not properly investigate HEPA filter stains. Complaint investigations were insufficient, lacking specific procedures for critical health hazards and comprehensive trending. Overall, investigations frequently lacked complete documentation, scientific justification for root causes, and timely completion.

These findings led the FDA to recommend withholding approval for several New Drug Applications. Company management was informed of their responsibility to promptly correct these issues, as failure to do so could result in further regulatory action. Many of the identified deficiencies were similar to those cited during a previous inspection in 2016, which had resulted in an Official Action Indicated (OAI) classification.