FDA Inspection
Fertility Cryobank LLCFertility Cryobank LLC – FDA Inspection, Feb 3, 2012
Record Details
This FDA Inspection record concerns Fertility Cryobank LLC, with an inspection on February 3, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Fertility Cryobank LLC
- Inspection Date
- February 3, 2012
- Product Type
- Biologics
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ID · d30967a4-b77c-4e1c-b14d-f60cd927b215
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766600
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.55(d)(4)Ten year retention
- 21 CFR 1271.75(e)Abbreviated procedure
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Other FDA inspections of Fertility Cryobank LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fertility Cryobank LLC
- FDA Inspection 840334 - 2013-07-12
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