FDA Inspection
Xytex Cryo InternationalXytex Cryo International – FDA Inspection, Dec 16, 2013
Record Details
This FDA Inspection record concerns Xytex Cryo International, with an inspection on December 16, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Xytex Cryo International
- Inspection Date
- December 16, 2013
- Product Type
- Biologics
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ID · 5a06d4c7-262c-414a-af0d-fa2a52d7cded
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859009
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.60(b)Identified as quarantined, distinguishable
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Other FDA inspections of Xytex Cryo International
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 15, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 21, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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