Warning letter
Auto-Chlor System LLC: warning letter of Dec 20, 2022
FDA warning letter 641808 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 641808 |
|---|---|
| Company | Auto-Chlor System LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 20, 2022 |
| Posted date | Jan 10, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 330, 211.25(a), 211.67(b), 211.84(d)(1), 211.100(a), 211.165(a), 211.165(b), 211.166(a), 211.180(e), 201.128, 211.22, 211.34 and 2 more |
| Inspection city | Hapeville |
| Inspection ZIP | 30354 |
| Inspection start date | Jul 5, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: