Allergan Sales, LLC – FDA EIR, Mar 20, 2009

An FDA inspection of Allergan Sales, LLC's ophthalmic drug manufacturing facility in Waco, TX, was conducted from March 16-20, 2009. The inspection focused on the company's Quality and Production Systems, including sterile operations, and adhered to regulatory guidelines such as CPGM 7356.002 (Drug Manufacturing Inspections) and CPGM 7356.002A (Sterile Drug Products), utilizing an Abbreviated Inspection Option. The facility also ensures compliance with U.S. FDA, ISO, and UK DHSS criteria.

Throughout the five-day assessment, which involved a comprehensive review of annual product reports, complaint handling, change controls, production processes for sterile and non-sterile products (including Restasis, Lumigan, and Refresh Lacri-lube), employee training programs, environmental monitoring, and purified water systems, no significant deficiencies were observed. Consequently, no FDA-483, Inspectional Observations, was issued to Allergan Sales, LLC, mirroring the outcome of the previous inspection in 2007.

During discussions, the firm outlined its proactive management of the acetonitrile shortage, with FDA investigators providing general advice regarding contact with the agency's Center for Drug Evaluation and Research (CDER) for any analytical method or product submission changes. No specific required actions or violations were identified, reaffirming the facility's adherence to established regulatory standards.