Warning letter
Safecor Health, LLC: warning letter of Sep 5, 2023
FDA warning letter 657886 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 657886 |
|---|---|
| Company | Safecor Health, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 5, 2023 |
| Posted date | Sep 12, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.34, 211.67(b), 211.84(d)(2), 211.130(e) |
| Inspection city | Woburn |
| Inspection ZIP | 01801 |
| Inspection start date | Mar 7, 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: