483
American Contract Systems, Inc.American Contract Systems, Inc. – FDA 483, Mar 21, 2025
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.
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- Florida District Office
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ID · 6d107f7a-8148-462b-a3eb-fb52218f0153
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