FDA Inspection 989639 — Alcami Corporation
The FDA completed an inspection of Alcami Corporation on August 23, 2016 in Edison, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |