# FDA 483 - SRI Healthcare LLC - January 12, 2023

Source: https://www.keypedia.com/records/483/sri-healthcare-llc/2f4204d2-afbb-413c-9e11-420a65862557

> FDA 483 for SRI Healthcare LLC on January 12, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SRI Healthcare LLC
- Inspection Date: 2023-01-12
- Product Type: other
- Office Name: New Orleans District Office
- Summary: During an inspection, SRI Healthcare LLC, a sterilizer/repackager/relabeler in Chattanooga, TN, was cited for failing to adequately establish and control production processes. Specifically, the firm did not properly document sterilizer cycle deviations, sterilizer checks, and monthly maintenance activities for washers and sterilizers. This indicates significant deficiencies in their quality system's process control and documentation practices.

## Related Documents

- [483 - 2025-07-10](https://www.keypedia.com/records/483/sri-healthcare-llc/6d027d8b-1336-484e-8685-1097f78b707e)

## Related Officers

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

Company: https://www.keypedia.com/companies/sri-healthcare-llc/3cd27b19-023c-4186-ab28-315b3955f46b

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