FDA Inspection 1267356 — Catalent Greenville Inc
The FDA completed an inspection of Catalent Greenville Inc on October 24, 2025 in Greenville, NC. 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
- October 24, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Greenville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1912 | 21 CFR 211.166(a) | Written program not followed |