# FDA 483 - American Contract Systems, Inc. - August 16, 2019

Source: https://www.keypedia.com/records/483/american-contract-systems-inc/4e017c44-088d-4420-a58a-c1c7bf90171c

> FDA 483 for American Contract Systems, Inc. on August 16, 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: 2019-08-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: American Contract Systems, Inc. in Tampa, FL, a medical device manufacturer, received a Form FDA 483 with eight observations following an inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate sterilization and software validation, insufficient design controls, and failures in purchasing controls, complaint handling, and CAPA procedures. These issues indicate a systemic lack of established and followed procedures critical for ensuring product quality and safety.

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## Related Officers

- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6