# FDA 483 - American Contract Systems - July 25, 2019

Source: https://www.keypedia.com/records/483/american-contract-systems/93f94ea1-c677-41f1-9dc8-681675e3159e

> FDA 483 for American Contract Systems on July 25, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: American Contract Systems
- Inspection Date: 2019-07-25
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: American Contract Systems in Zelienople, PA, a medical device assembler and contract sterilizer, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate validation of sterilization processes and device software, ineffective corrective and preventive action procedures, and poorly maintained device master records. These issues indicate a lack of control over critical manufacturing and quality system processes.

## Related Officers

- [Katelyn A. Staub-Zamperini](https://www.keypedia.com/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)

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