FDA Inspection 1270448 — AVEM Labs LLC
The FDA completed an inspection of AVEM Labs LLC on May 21, 2025 in Las Vegas, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12372 | 21 CFR 1271.200(c) | Calibrated per established schedules |
| 12378 | 21 CFR 1271.210(d)(1) | Receipt documentation maintained |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12407 | 21 CFR 1271.250(b) | Verification of label accuracy, legibility, integrity |