# FDA 483 - American Contract Systems, Inc. - April 08, 2022

Source: https://www.keypedia.com/records/483/american-contract-systems-inc/359820bc-fe4e-4995-b8b3-4380c7bc709f

> FDA 483 for American Contract Systems, Inc. on April 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Contract Systems, Inc.
- Inspection Date: 2022-04-08
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of American Contract Systems, Inc. in Temple Terrace, FL, revealed significant deficiencies in their quality system for manufacturing sterile surgical kits. The firm was cited for inadequate process validation for sterilization, a repeat observation for lacking design control procedures, and repeated issues with their corrective and preventive action system. Additionally, the inspection found failures in establishing and documenting employee training.

## Related Documents

- [WARNING_LETTER - 2019-10-04](https://www.keypedia.com/records/warning_letter/american-contract-systems-inc/869603af-fe2d-4968-93e1-6fc0774973cf)
- [WARNING_LETTER - 2024-08-14](https://www.keypedia.com/records/warning_letter/american-contract-systems-inc/3d5cb934-f48f-4a9f-b218-51e973d26c07)

## Related Officers

- [Recall Coordinator](https://www.keypedia.com/people/emma-schaefer/10299982-dce6-4fea-a3e9-8167030b0331)
- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/american-contract-systems-inc/a472a3ba-5229-4a20-a8bb-0e10b1be11f7

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7