FDA Inspection
Cook General BioTechnology, LLCCook General BioTechnology, LLC – FDA Inspection, Dec 20, 2010
Record Details
This FDA Inspection record concerns Cook General BioTechnology, LLC, with an inspection on December 20, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 20, 2010
- Product Type
- Biologics
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ID · 1eada283-0f13-4f3f-87d1-7c2a2b916def
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702541
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(d)(1)(ii)Results, interpretation of CD screening
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.60(a)Completion of eligibility determination
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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 |
| January 12, 2012 | 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 763384 - 2012-01-12
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