Warning letter
PQ Pharmacy, LLC: warning letter of Oct 10, 2025
FDA warning letter 715795 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 715795 |
|---|---|
| Company | PQ Pharmacy, LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Oct 10, 2025 |
| Posted date | Dec 2, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 200.10(b), 210.1(b), 201.115, 211.42(c)(10)(iv), 211.100(a), 211.113(b), 211.192, 310.305(b) |
| Inspection city | Brooksville |
| Inspection ZIP | 34604 |
| Inspection start date | Mar 25, 2025 |
| 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: