Mayo Clinic Hospital - Rochester, Rochester, MN – FDA Inspections

Inspection records and compliance data for Mayo Clinic Hospital - Rochester in Rochester, Minnesota. 7 FDA inspections on record, last inspected January 27, 2026.

Company Profile

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

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 3
NAI: 4
Form 483s: 0
Warning letters: 0

First inspected August 4, 2009. Last inspected January 27, 2026.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs1 inspection
Following manufacturer"s instructions1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
January 27, 2026	NAI	Biologics · Blood and Blood Products	1304168
October 26, 2018	NAI	Biologics · Blood and Blood Products	1072546
November 1, 2016	NAI	Biologics · Blood and Blood Products	994643
April 29, 2015	VAI	Biologics · Blood and Blood Products	924699
April 5, 2013	NAI	Biologics · Blood and Blood Products	828524
May 6, 2011	VAI	Biologics · Blood and Blood Products	727352
August 4, 2009	VAI	Biologics · Blood and Blood Products	603497

FDA documents

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

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