1241478
Auto-Chlor System LLC — FEI 3010164603
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 18, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hapeville, GA (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 |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |