FDA Inspection 1016325 — Amgen Manufacturing Limited LLC
The FDA completed an inspection of Amgen Manufacturing Limited LLC on May 10, 2017 in Juncos, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Juncos, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |