# American Contract Systems – FDA 483, Mar 25, 2022

Source: https://www.keypedia.com/records/483/american-contract-systems/d2e168aa-6b00-43c6-8b45-f10dcc62c769

> FDA 483 for American Contract Systems on March 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Contract Systems
- Inspection Date: 2022-03-25
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of American Contract Systems, a medical device manufacturer in Zelienople, PA, revealed significant deficiencies in their quality system. Observations included inadequate documentation for validated processes, unapproved process validation activities, and insufficient procedures for controlling non-conforming products. Additionally, the firm failed to ensure appropriate training and supervision for personnel working under special environmental conditions, including an employee conducting kitting operations from their residence.

## Related Documents

- [483 - 2019-07-25](https://www.keypedia.com/records/483/american-contract-systems/93f94ea1-c677-41f1-9dc8-681675e3159e) — date: July 25, 2019

## Related Officers

- [Katelyn A. Staub-Zamperini](https://www.keypedia.com/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)
- [issuing_officer](https://www.keypedia.com/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.keypedia.com/companies/american-contract-systems/9d914ae9-8f1e-4420-9ae2-b52596633d9d

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8