FDA Inspection 1157831 — Catalent Massachusetts, LLC
The FDA completed an inspection of Catalent Massachusetts, LLC on November 30, 2021 in Chelsea, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 30, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chelsea, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |