FDA Inspection 1014416 — Center For Organ Recovery & Education
The FDA completed an inspection of Center For Organ Recovery & Education on June 16, 2017 in Pittsburgh, PA. 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
- June 16, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |