Warning letter
PReye, LLC: warning letter of Aug 18, 2026
FDA warning letter 732141 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 732141 |
|---|---|
| Company | PReye, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Issue date | Aug 18, 2026 |
| Posted date | Sep 1, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.34, 201.128, 211.42(c)(10), 211.63 |
| Inspection city | Wheat Ridge |
| Inspection ZIP | 80033 |
| Inspection start date | Mar 17, 2026 |
| 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: