Warning letter
Similasan AG: warning letter of Sep 11, 2023
FDA warning letter 658878 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 658878 |
|---|---|
| Company | Similasan AG |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Issue date | Sep 11, 2023 |
| Posted date | Sep 12, 2023 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.194(a), 211.160(b), 211.113(b), 211.22(a), 200.50(b)(1) |
| Inspection city | Jonen |
| Inspection start date | Mar 27, 2023 |
| 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: