Warning letter
Stokes Healthcare Inc. dba Epicur Pharma: warning letter of Apr 2, 2024
FDA warning letter 677624 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 677624 |
|---|---|
| Company | Stokes Healthcare Inc. dba Epicur Pharma |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Apr 2, 2024 |
| Posted date | Oct 22, 2024 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.192, 200.10(b), 211.22(a), 211.22(d), 211.42(c)(10)(iii), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.100(a), 211.113(b), 211.160(b), 210.1(b) and 1 more |
| Inspection city | Mount Laurel |
| Inspection ZIP | 08054 |
| Inspection start date | Sep 26, 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: