FDA Inspection 1283430 — Blephex, LLC
The FDA completed an inspection of Blephex, LLC on November 19, 2025 in Brentwood, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Brentwood, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3696 | 21 CFR 820.100(b) | Documentation |