# FDA 483 - SRI Healthcare LLC - July 10, 2025

Source: https://www.keypedia.com/records/483/sri-healthcare-llc/3e18e692-378d-4a37-999c-79e1db9e5654

> FDA 483 for SRI Healthcare LLC on July 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SRI Healthcare LLC
- Inspection Date: 2025-07-10
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of SRI Healthcare LLC, a repacker in Mebane, NC, revealed significant deficiencies in their quality system oversight. The firm failed to conduct required management review meetings and did not perform scheduled quality audits. These issues indicate a breakdown in maintaining the suitability and effectiveness of their quality system, potentially impacting the quality of sterilized kits distributed to medical facilities.

## Related Officers

- [Lashawn M. Elam](https://www.keypedia.com/people/lashawn-m-elam/23bee423-c2f7-4977-bc32-2d4c40fc521f)

Company: https://www.keypedia.com/companies/sri-healthcare-llc/93b5e593-85a4-4337-a8a5-bdaee13321bf

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7