FDA Inspection 714457 — Interstate Blood Bank Inc of Missouri
The FDA completed an inspection of Interstate Blood Bank Inc of Missouri on February 16, 2011 in Jackson, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Jackson, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 81 | 21 CFR 606.100(b)(2) | Donor qualifying tests & measurements |