Warning letter
AnuMed International, LLC: warning letter of Aug 20, 2024
FDA warning letter 674310 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 674310 |
|---|---|
| Company | AnuMed International, LLC |
| Subject | Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded |
| Issue date | Aug 20, 2024 |
| Posted date | Aug 27, 2024 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 201.5, 211.22, 211.34, 310.530, 330, 207.77(a), 211.25(a), 211.84(d)(1), 211.100(a), 211.160(b), 211.180(a), 211.180(e) and 1 more |
| Inspection city | Phoenix |
| Inspection ZIP | 85040 |
| Inspection start date | Nov 1, 2023 |
| 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: