FDA Inspection 1251906 — Alon Medical Technology
The FDA completed an inspection of Alon Medical Technology on October 16, 2024 in Flowood, MS. 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
- October 16, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Flowood, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |