1009155
Acme United Corporation — FEI 1030186
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rocky Mount, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1958 | 21 CFR 211.180(f) | Responsible firm officials notified in writing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |