FDA Inspection 1080109 — Catalent Pharma Solutions, LLC
The FDA completed an inspection of Catalent Pharma Solutions, LLC on Feb 22, 2019 in Saint Petersburg, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |