Warning letter
ProRx, LLC: warning letter of Dec 20, 2024
FDA warning letter 696742 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 696742 |
|---|---|
| Company | ProRx, LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Dec 20, 2024 |
| Posted date | Jan 28, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.28(a), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.56(a), 211.84(d)(1), 211.113(b), 211.166(a), 210.1(b), 310.305(b), 310.305(c)(1)(i), 310.305(d), 310.305(c)(2) and 5 more |
| Inspection city | Exton |
| Inspection ZIP | 19341 |
| Inspection start date | Jul 15, 2024 |
| 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: