FDA Inspection 583221 — Acme United Corporation
The FDA completed an inspection of Acme United Corporation on May 6, 2009 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rocky Mount, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |