Larkin Community Hospital IRBMay 21, 2025

FDA 483 - Larkin Community Hospital IRB - May 21, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Larkin Community Hospital IRB

Record Details

An FDA inspection of Larkin Community Hospital IRB in South Miami, FL, revealed three significant issues. The Institutional Review Board failed to maintain detailed meeting minutes, including accurate attendance and voting records. Additionally, the IRB did not properly maintain a current list of its members or update its registration information regarding changes to the contact person in a timely manner.

Company: Larkin Community Hospital IRB
Inspection Date: May 21, 2025
Product Type: Other
Office: Florida District Office
People: Chantae D. Mitchell
Emily A. Baldwin (investigator)

Open in Dashboard

ID · 0e344049-890a-4411-9980-08905294cfb3