# FDA 483 - American Contract Systems, Inc. - October 04, 2019

Source: https://www.globalkeysolutions.net/records/483/american-contract-systems-inc/6268ef37-88f2-48e5-b176-58035f1f6bea

> FDA 483 for American Contract Systems, Inc. on October 04, 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: 2019-10-04
- Product Type: device
- Office Name: Dallas District Office
- Summary: The FDA inspected American Contract Systems, Inc. in Houston, TX, and found significant deficiencies in their sterilization process validation and control. The firm failed to adequately validate its sterilization processes, monitor critical parameters, revalidate processes after changes, and maintain complete device master records. These issues led to potential sterility assurance problems and product quality concerns, including multiple complaints of foreign matter in sterilized surgical packs.

## Related Officers

- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/american-contract-systems-inc/634148dc-848f-4ed7-a832-655aa6b420d5

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9