FDA Inspection 951524 — AVEM Medical LLC
The FDA completed an inspection of AVEM Medical LLC on November 19, 2015 in Irving, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |