FDA Inspection 572448 — Arthur M Blank Hospital Inc
The FDA completed an inspection of Arthur M Blank Hospital Inc on March 27, 2009 in Atlanta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |