FDA Inspection
Mayo Clinic RochesterMayo Clinic Rochester – FDA Inspection, Dec 10, 2010
Record Details
This FDA Inspection record concerns Mayo Clinic Rochester, with an inspection on December 10, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Mayo Clinic Rochester
- Inspection Date
- December 10, 2010
- Product Type
- Biologics
View Company Profile
ID · f0345bac-dc66-4e24-8d64-18142c0f22c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 701472
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.210(d)(2)Verification elements
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.260(b)Storage temperatures appropriate
- 21 CFR 1271.210(d)(1)Receipt documentation elements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mayo Clinic Rochester
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 31, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 4, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 30, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 27, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Mayo Clinic Rochester
- FDA Inspection 1224988 - 2023-11-02
- FDA Inspection 1072983 - 2018-10-31
- FDA Inspection 994645 - 2016-11-04
- FDA Inspection 924435 - 2015-04-30
- FDA Inspection 838096 - 2013-06-27
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.