FDA 483 - Actavis Laboratories UT, Inc. - March 19, 2024

An FDA inspection of Actavis Laboratories UT, Inc. in Salt Lake City, UT, revealed significant deficiencies in facility maintenance, environmental monitoring, and quality control. The firm failed to maintain clean and sanitary manufacturing areas, exhibited inadequate environmental monitoring and cleaning validation, and demonstrated failures in laboratory investigation and CAPA effectiveness. These issues indicate a lack of robust control over drug manufacturing processes, particularly for Lidocaine Topical 5% Patch.