FDA Inspection 700992 — North Florida Regional Medical Center
The FDA completed an inspection of North Florida Regional Medical Center on Dec 8, 2010 in Gainesville, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 8, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |