FDA Inspection 700530 — Baptist Health Floyd
The FDA completed an inspection of Baptist Health Floyd on Nov 30, 2010 in New Albany, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 30, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New Albany, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |
| 98 | 21 CFR 606.100(c) | Thorough investigations |