FDA Inspection 1081814 — Acme United Corporation
The FDA completed an inspection of Acme United Corporation on Mar 8, 2019 in Brooksville, FL. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 8, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |