American Contract Systems – FDA 483, Mar 25, 2022

An FDA inspection of American Contract Systems, a medical device manufacturer in Zelienople, PA, revealed significant deficiencies in their quality system. Observations included inadequate documentation for validated processes, unapproved process validation activities, and insufficient procedures for controlling non-conforming products. Additionally, the firm failed to ensure appropriate training and supervision for personnel working under special environmental conditions, including an employee conducting kitting operations from their residence.