FDA 483 - American Contract Systems Inc - June 02, 2025
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This FDA Form 483 was issued to American Contract Systems Inc in Tiffin, OH, following an inspection of their medical device kitting and EO sterilizer facility. The inspection revealed significant deficiencies across multiple quality system areas, primarily concerning inadequate procedures for product acceptance, nonconformance control, product identification, and sampling methods. These issues indicate a moderate level of non-compliance with quality system regulations.
ID · f813d2b5-b65e-4f2f-8db6-f855fa30ece2