FDA Inspection 1195585 — Catalent Pharma Solutions LLC
The FDA completed an inspection of Catalent Pharma Solutions LLC on December 15, 2022 in Morrisville, NC. 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
- December 15, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morrisville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |