1005214
Auto-Chlor System LLC — FEI 3010164603
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 8, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hapeville, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1776 | 21 CFR 211.150(a) | Distribution of oldest approved drugs |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |