1131607
Catalent Pharma Solutions LLC — FEI 1000110912
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 28, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morrisville, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |