FDA Inspection 862062 — AVEM Medical LLC
The FDA completed an inspection of AVEM Medical LLC on January 14, 2014 in Irving, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 14, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |