University of Rochester - Strong Memorial Hospital, Rochester, NY – FDA Inspections

Inspection records and compliance data for University of Rochester - Strong Memorial Hospital in Rochester, New York. 8 FDA inspections on record, 1 Form 483, last inspected July 24, 2026.

Company Profile

This profile covers University of Rochester - Strong Memorial Hospital based in Rochester, New York, United States.

FDA Inspection History

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

First inspected April 12, 2010. Last inspected July 24, 2026.

Most cited issue areas

Donor's Acknowledgment - Exculpatory language1 inspection
Donor's Acknowledgment Procedures1 inspection
Notification to and approval from CBER1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
July 24, 2026	Not classified	Biologics · Blood and Blood Products	1327728
September 13, 2023	NAI	Biologics · Blood and Blood Products	1218862
January 11, 2018	NAI	Biologics · Blood and Blood Products	1039885
September 6, 2016	NAI	Biologics · Blood and Blood Products	985227
December 3, 2015	NAI	Biologics · Blood and Blood Products	952369
March 5, 2014	NAI	Biologics · Blood and Blood Products	870796
January 17, 2012	NAI	Biologics · Blood and Blood Products	763897
April 12, 2010	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	657409

FDA documents

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

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