FDA Inspection 1191152 — AVEM Labs LLC
The FDA completed an inspection of AVEM Labs LLC on November 22, 2022 in Las Vegas, NV. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 22, 2022
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |