# FDA 483 - Benuvia Operations, LLC - January 23, 2026

Source: https://www.keypedia.com/records/483/benuvia-operations-llc/21ed57e8-9f4d-46c3-9e4d-4566b40345b8

> FDA 483 for Benuvia Operations, LLC on January 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Benuvia Operations, LLC
- Inspection Date: 2026-01-23
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Benuvia Operations, LLC in Round Rock, TX, was cited with three observations during an FDA inspection. The firm was found to have issues with incomplete laboratory records, specifically regarding data integrity and instrument qualification for FTIR. Additionally, the company lacked adequate systems and written procedures to comply with the Drug Supply Chain Security Act (DSCSA) verification requirements. Finally, the inspection revealed deficiencies in equipment cleaning validation, as microbiological testing was not performed during clean hold time studies for production tanks.

## Related Officers

- [investigator](https://www.keypedia.com/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)

Company: https://www.keypedia.com/companies/benuvia-operations-llc/77e6325c-aadf-4751-9ec3-b72a1a139522

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9