FDA Inspection 1044788 — Alcami Corporation
The FDA completed an inspection of Alcami Corporation on March 19, 2018 in Edison, NJ. 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
- March 19, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |