891859
Amarin Pharma Inc. — FEI 3010326898
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 9, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bedminster, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6839 | 21 CFR 314.80(e)(2) | Failure to identify post marketing study reports |