Warning letter
Sanit Technologies, LLC dba Durisan: warning letter of Jul 27, 2021
FDA warning letter 614278 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 614278 |
|---|---|
| Company | Sanit Technologies, LLC dba Durisan |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 27, 2021 |
| Posted date | Aug 10, 2021 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.160(b), 211.22, 211.63, 211.192, 211.166(a) |
| Inspection city | Sarasota |
| Inspection ZIP | 34243 |
| Inspection start date | Mar 1, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: