FDA Inspection 1061201 — Amgen Manufacturing Limited LLC
The FDA completed an inspection of Amgen Manufacturing Limited LLC on August 6, 2018 in Juncos, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 6, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Juncos, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |