FDA Inspection 1012163 — Acme United Corporation
The FDA completed an inspection of Acme United Corporation on May 26, 2017 in Brooksville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1420 | 21 CFR 211.42(c)(9) | Control / Lab Operations Area |
| 1546 | 21 CFR 211.125(d) | Destruction of excess labels with lot numbers |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |