FDA Inspection
California Cryobank LLCCalifornia Cryobank LLC – FDA Inspection, Sep 25, 2018
Record Details
This FDA Inspection record concerns California Cryobank LLC, with an inspection on September 25, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · 8f13ca1e-8395-4330-b90a-c2a743456144
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066638
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of California Cryobank LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 18, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 27, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 15, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for California Cryobank LLC
- FDA Inspection 1246354 - 2024-08-06
- FDA Inspection 989122 - 2016-08-18
- FDA Inspection 868705 - 2014-02-27
- FDA Inspection 844713 - 2013-08-15
- FDA Inspection 746500 - 2011-09-23
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.