Mayo Clinic Rochester, Rochester, MN – FDA Inspections

Inspection records and compliance data for Mayo Clinic Rochester in Rochester, Minnesota. 7 FDA inspections on record, last inspected November 02, 2023.

Company Profile

This profile covers Mayo Clinic Rochester based in Rochester, Minnesota, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 2
NAI: 5
Form 483s: 0
Warning letters: 0

First inspected August 26, 2009. Last inspected November 2, 2023.

Most cited issue areas

Donors with risks not determined ineligible1 inspection
Receipt documentation elements1 inspection
Storage temperatures appropriate1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
November 2, 2023	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1224988
October 31, 2018	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1072983
November 4, 2016	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	994645
April 30, 2015	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	924435
June 27, 2013	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	838096
December 10, 2010	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	701472
August 26, 2009	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	609554

FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

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Alexander Khoruts, M.D., Sponsor-Investigator

Rice, Kathryn L., MD, Clinical Investigator