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

Source: https://www.globalkeysolutions.net/records/483/american-contract-systems-inc/6d107f7a-8148-462b-a3eb-fb52218f0153

> FDA 483 for American Contract Systems, Inc. on March 21, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Contract Systems, Inc.
- Inspection Date: 2025-03-21
- Product Type: other
- Office Name: Florida District Office
- Summary: 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.

## Related Officers

- [Alex J. Wild](https://www.globalkeysolutions.net/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.globalkeysolutions.net/companies/american-contract-systems-inc/49bb6e81-6639-4830-bea1-01626ec6941c

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9