FDA Inspection 1309158 — PReye LLC
The FDA completed an inspection of PReye LLC on March 19, 2026 in Wheat Ridge, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 19, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wheat Ridge, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |