FDA Inspection
Cryo-Cell International, IncCryo-Cell International, Inc – FDA Inspection, Dec 4, 2013
Record Details
This FDA Inspection record concerns Cryo-Cell International, Inc, with an inspection on December 4, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Cryo-Cell International, Inc
- Inspection Date
- December 4, 2013
- Product Type
- Biologics
View Company Profile
ID · 13b2498d-4b1b-4e4d-a813-67464bf10ec0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857538
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.230(a)Validation & approval--established procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cryo-Cell International, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 16, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 6, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 19, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Cryo-Cell International, Inc
- FDA Inspection 1231513 - 2024-01-29
- FDA Inspection 1165696 - 2022-03-16
- FDA Inspection 1048890 - 2018-02-06
- FDA Inspection 1026394 - 2017-09-19
- FDA Inspection 949175 - 2015-11-20
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