# FDA 483 - Engineered Medical Systems, LLC - February 10, 2023

Source: https://www.keypedia.com/records/483/engineered-medical-systems-llc/46a5e281-f41d-44ae-8c28-7eb1ed6225da

> FDA 483 for Engineered Medical Systems, LLC on February 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Engineered Medical Systems, LLC
- Inspection Date: 2023-02-10
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Engineered Medical Systems, LLC in Bartlett, TN, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company failed to adequately investigate nonconformities, implement effective corrective actions, verify their effectiveness, and maintain proper documentation for CAPA activities. These issues indicate a systemic problem in addressing product-related complaints and preventing their reoccurrence.

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)
- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)
- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/engineered-medical-systems-llc/4e8fb9ce-89a7-4a70-b6db-3b70b6188e84

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea