FDA Inspection 1215112 — ActiveAID Medical Solutions LLC
The FDA completed an inspection of ActiveAID Medical Solutions LLC on August 18, 2023 in Sabana Grande, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 18, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sabana Grande, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |