FDA Inspection 1205588 — AVEM Medical LLC
The FDA completed an inspection of AVEM Medical LLC on May 18, 2023 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
- May 18, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12412 | 21 CFR 1271.260(b) | Storage temperatures appropriate |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |