FDA Inspection 1283450 — Benuvia Operations, LLC
The FDA completed an inspection of Benuvia Operations, LLC on January 23, 2026 in Round Rock, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 23, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Round Rock, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |