FDA Inspection 702541 — Cook General BioTechnology, LLC
The FDA completed an inspection of Cook General BioTechnology, LLC on Dec 20, 2010 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12245 | 21 CFR 1271.55(d)(1)(ii) | Results, interpretation of CD screening |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |