FDA 483 - American Contract Systems Inc - August 14, 2024

An FDA inspection of American Contract Systems Inc in Tiffin, OH, a medical device manufacturer, revealed significant deficiencies in their quality management system. Observations included inadequate procedures for incoming product acceptance, an organizational structure not ensuring compliance with 21 CFR 820, incomplete design history files, and insufficient documentation for process and software validation. These issues indicate a broad lack of control over critical manufacturing processes and design activities.