Warning letter
Pharmedica USA, LLC: warning letter of Apr 28, 2023
FDA warning letter 648269 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 648269 |
|---|---|
| Company | Pharmedica USA, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 28, 2023 |
| Posted date | May 16, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.34, 211.188, 211.192, 211.22(a), 211.84(d)(1), 211.100(a), 211.113(b), 211.165(a), 211.165(b), 211.166(a) |
| Inspection city | Phoenix |
| Inspection ZIP | 85027 |
| Inspection start date | Nov 1, 2022 |
| 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: