FDA 483 - Accupack Midwest Inc - February 27, 2024

An FDA inspection of Accupack Midwest Inc. in Cincinnati, OH, revealed four repeat observations concerning the manufacturing of OTC drug products. The firm was cited for lacking written procedures for component sampling and water system monitoring, failing to qualify critical equipment and water systems, and not validating production processes. Additionally, issues with equipment cleaning and contamination prevention were noted, indicating significant deficiencies in their quality control systems.