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

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.