FDA 483 - Allergan Sales, LLC - October 28, 2016

An FDA inspection of Allergan Sales, LLC in Waco, TX, revealed significant deficiencies across multiple systems, including incomplete laboratory records, inadequate data controls, and a failure to thoroughly investigate batch failures. The firm also exhibited issues with aseptic processing areas, persistent manufacturing problems leading to underfilled vials and particulates, and a lack of control over electronic systems and sampling procedures. These findings indicate a systemic lack of oversight and control over critical manufacturing and quality processes for sterile ophthalmic drug products.