Warning letter
Sircle Laboratories, LLC: warning letter of Sep 21, 2021
FDA warning letter 615098 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 615098 |
|---|---|
| Company | Sircle Laboratories, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 21, 2021 |
| Posted date | Oct 19, 2021 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.130, 211.198(a) |
| Inspection city | Madison |
| Inspection ZIP | 39110 |
| Inspection start date | Apr 13, 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: