Mayo Clinic Rochester, Division of Transfusion Medicine, Rochester, MN – FDA Inspections

Inspection records and compliance data for Mayo Clinic Rochester, Division of Transfusion Medicine in Rochester, Minnesota. 8 FDA inspections on record, last inspected September 17, 2025.

Company Profile

This profile covers Mayo Clinic Rochester, Division of Transfusion Medicine based in Rochester, Minnesota, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 1
NAI: 7
Form 483s: 0
Warning letters: 0

First inspected February 1, 2010. Last inspected September 17, 2025.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs1 inspection
Person performing, test results, interpretation1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
September 17, 2025	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1286320
November 15, 2023	NAI	Biologics · Blood and Blood Products	1225980
November 1, 2018	NAI	Biologics · Blood and Blood Products	1073614
November 2, 2016	NAI	Biologics · Blood and Blood Products	994642
June 25, 2015	NAI	Biologics · Blood and Blood Products	934199
February 8, 2013	NAI	Biologics · Blood and Blood Products	819601
February 18, 2011	NAI	Biologics · Blood and Blood Products	710444
February 1, 2010	VAI	Biologics · Blood and Blood Products	649956

FDA documents

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

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