FDA Inspection 1164132 — Alon Medical Technology
The FDA completed an inspection of Alon Medical Technology on Mar 8, 2022 in Metairie, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 8, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Metairie, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12340 | 21 CFR 1271.180(d) | Adopted from another organization |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |