FDA Inspection 1097604 — AVEM Medical LLC
The FDA completed an inspection of AVEM Medical LLC on July 25, 2019 in Irving, TX. 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
- July 25, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12340 | 21 CFR 1271.180(d) | Adopted from another organization |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12446 | 21 CFR 1271.290(a) | HCT/Ps not tracked |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |