FDA Inspection 763384 — Cook General BioTechnology, LLC
The FDA completed an inspection of Cook General BioTechnology, LLC on Jan 12, 2012 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 12, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |