# FDA 483 - American Contract Systems, Inc. - September 10, 2019

Source: https://www.globalkeysolutions.net/records/483/american-contract-systems-inc/9a0d1233-9590-4fda-848b-e1205bd7c495

> FDA 483 for American Contract Systems, Inc. on September 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Contract Systems, Inc.
- Inspection Date: 2019-09-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of American Contract Systems, Inc. in Kansas City, MO, a manufacturer, repackager/relabeler, and contract sterilizer, revealed significant deficiencies in their quality system. The inspection cited repeat observations regarding inadequate procedures for controlling non-conforming products, establishing acceptance activities, and managing employee training. These findings suggest a systemic failure to maintain proper quality controls.

## Related Documents

- [483 - 2022-03-02](https://www.globalkeysolutions.net/records/483/american-contract-systems-inc/4a12c929-2e85-43a3-96d9-3cc7fa0a36e3)

## Related Officers

- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.globalkeysolutions.net/companies/american-contract-systems-inc/32bd748c-aa03-49ae-836f-fea98dd32d50

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8