FDA Inspection
BIOinnovations LLCBIOinnovations LLC – FDA Inspection, Dec 21, 2009
Record Details
This FDA Inspection record concerns BIOinnovations LLC, with an inspection on December 21, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- BIOinnovations LLC
- Inspection Date
- December 21, 2009
- Product Type
- Biologics
View Company Profile
ID · 6b11f714-f517-48cb-b038-f5dca9d15ec1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634775
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of BIOinnovations LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 13, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 26, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for BIOinnovations LLC
- FDA Inspection 986920 - 2016-10-03
- FDA Inspection 890901 - 2014-08-13
- FDA Inspection 778604 - 2012-04-26
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