FDA Inspection 1262051 — BioXtek LLC
The FDA completed an inspection of BioXtek LLC on Feb 26, 2025 in Pompano Beach, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 26, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |