FDA Inspection 1285106 — Alcami Carolinas Corporation
The FDA completed an inspection of Alcami Carolinas Corporation on September 26, 2025 in Wilmington, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 26, 2025
- Fiscal Year
- 2025
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Wilmington, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |