American Contract Systems, Inc.March 21, 2025

FDA 483 - American Contract Systems, Inc. - March 21, 2025

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Record Details

American Contract Systems, Inc., a contract sterilizer in Fort Myers, FL, was inspected by the FDA from March 18-21, 2025. The inspection revealed a significant issue with the firm's procedures for handling nonconforming product, specifically regarding documentation and disposition after "bad seal" failures. This indicates a lapse in quality system controls for product integrity.

Company: American Contract Systems, Inc.
Inspection Date: March 21, 2025
Product Type: Other
Office: Florida District Office
Person: Alex J. Wild

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ID · 6d107f7a-8148-462b-a3eb-fb52218f0153