FDA Inspection
Cryos International-New York LLCCryos International-New York LLC – FDA Inspection, Nov 7, 2013
Record Details
This FDA Inspection record concerns Cryos International-New York LLC, with an inspection on November 7, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 7, 2013
- Product Type
- Biologics
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ID · d74194cc-f846-4e54-a5b2-05b3a703b1d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 853447
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
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Other FDA inspections of Cryos International-New York LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 13, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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