FDA Inspection
CCB-MCB LLCCCB-MCB LLC – FDA Inspection, Jul 2, 2013
Record Details
This FDA Inspection record concerns CCB-MCB LLC, with an inspection on July 2, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CCB-MCB LLC
- Inspection Date
- July 2, 2013
- Product Type
- Biologics
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ID · 6c9ce537-29f3-41ca-963a-9205335ffe8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837334
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.75(a)(2)Risks associated with xenotransplantation
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CCB-MCB LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 27, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 4, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 28, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for CCB-MCB LLC
- FDA Inspection 1176120 - 2022-07-22
- FDA Inspection 1069251 - 2018-09-27
- FDA Inspection 981774 - 2016-08-04
- FDA Inspection 721891 - 2011-04-28
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