Mount Sinai Medical Center-IRB, Miami Beach, FL – FDA Inspections

Inspection records and compliance data for Mount Sinai Medical Center-IRB in Miami Beach, Florida. 4 FDA inspections on record, last inspected November 18, 2025.

Company Profile

This profile covers Mount Sinai Medical Center-IRB based in Miami Beach, Florida, United States.

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 1
NAI: 2
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected October 20, 2009. Last inspected November 18, 2025.

Most cited issue areas

Method to keep members advised1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
November 18, 2025	Not classified	Biologics, Human Drugs, Medical Devices & Rad Health	1292472
May 15, 2019	NAI	Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring	1091475
February 11, 2014	VAI	Human Drugs · Bioresearch Monitoring	866028
October 20, 2009	NAI	Human Drugs · Bioresearch Monitoring	621502

FDA documents

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

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