FDA Inspection 1086685 — Acme United Corporation
The FDA completed an inspection of Acme United Corporation on April 18, 2019 in Rocky Mount, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rocky Mount, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |