# FDA 483 - Lynch Biologics LLC - July 02, 2024

Source: https://www.keypedia.com/records/483/lynch-biologics-llc/7722056b-cd3c-4405-9be2-01d896bd897a

> FDA 483 for Lynch Biologics LLC on July 02, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lynch Biologics LLC
- Inspection Date: 2024-07-02
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Lynch Biologics LLC, a specification developer in Franklin, TN, was cited for significant deficiencies across its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, design changes, and risk analysis, leading to unaddressed quality concerns and unverified product specifications. Additionally, the firm failed to control nonconforming products and properly manage critical suppliers, indicating a broad breakdown in quality management.

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.keypedia.com/companies/lynch-biologics-llc/fb542392-1260-4ba6-9575-c64d70694478

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