FDA Inspection
Cook General BioTechnology, LLCCook General BioTechnology, LLC – FDA Inspection, Jan 12, 2012
Record Details
This FDA Inspection record concerns Cook General BioTechnology, LLC, with an inspection on January 12, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 12, 2012
- Product Type
- Biologics
View Company Profile
ID · e311f9b9-c7ee-45de-a6b4-1eba24cb600a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 763384
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cook General BioTechnology, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 10, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 20, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Cook General BioTechnology, LLC
- FDA Inspection 1049254 - 2018-03-08
- FDA Inspection 963325 - 2016-03-10
- FDA Inspection 702541 - 2010-12-20
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.