FDA Inspection 1259644 — Alcami Carolinas Corporation
The FDA completed an inspection of Alcami Carolinas Corporation on Jan 31, 2025 in Wilmington, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Wilmington, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |