FDA Inspection 1209484 — Amgen Manufacturing Limited LLC
The FDA completed an inspection of Amgen Manufacturing Limited LLC on July 5, 2023 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
- July 5, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Juncos, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |