FDA Inspection 1195321 — Catalent Pharma Solutions, LLC
The FDA completed an inspection of Catalent Pharma Solutions, LLC on January 11, 2023 in Winchester, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 11, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winchester, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |