FDA EIR - Bausch & Lomb Incorporated - February 28, 2020

An FDA surveillance inspection of Bausch & Lomb Irvine, an active pharmaceutical ingredient (API) manufacturer, was conducted from February 24-28, 2020. The inspection, carried out under drug manufacturing inspection guidelines and referencing Q7A guidance, evaluated the firm's compliance with current Good Manufacturing Practices (cGMP) as per section 501(a)(2)(b) of the Food Drug and Cosmetic Act. The inspection identified several deficiencies, resulting in a 6-item FDA Form 483. Key issues included the absence of quality agreements and inspection of contract testing laboratories, and inadequate support for the hyaluronidase API expiration date through stability studies. Furthermore, the quality control unit failed to adhere to established responsibilities and procedures, evidenced by document changes implemented without QA approval and overdue SOP reviews. Investigations into unexplained discrepancies, such as API batch failures and in-process control deviations, were deemed insufficient. Laboratory operations also showed deficiencies, with test procedures lacking clear integration parameters and quantitation limits, and a failure to thoroughly investigate abnormal chromatograms. The data review process was found to be inadequate, as electronic data and audit trails were not reviewed. Management acknowledged the findings and committed to providing a written response within 15 business days.