FDA Inspection 1119798 — Genesiscare
The FDA completed an inspection of Genesiscare on February 25, 2020 in Naples, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 25, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Naples, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |