FDA Inspection 555499 — Altrux Medical LLC
The FDA completed an inspection of Altrux Medical LLC on December 1, 2008 in Alpharetta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12312 | 21 CFR 1271.160(b)(2) | Procedures for complaints and other information |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12421 | 21 CFR 1271.265(a) | Acceptance criteria designed to prevent CD |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |