1085900
Amgen Manufacturing Limited LLC — FEI 1000110364
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Juncos, PR (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 9225 | 21 CFR 606.171 | Biological product deviation report |