897773
Catalent Pharma Solutions Limited — FEI 3003812585
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 12, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Swindon (United Kingdom)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |