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

Source: https://www.globalkeysolutions.net/records/483/larkin-community-hospital-irb/0e344049-890a-4411-9980-08905294cfb3

> FDA 483 for Larkin Community Hospital IRB on May 21, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Larkin Community Hospital IRB
- Inspection Date: 2025-05-21
- Product Type: other
- Office Name: Florida District Office
- Summary: 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.

## Related Documents

- [483 - 2021-11-19](https://www.globalkeysolutions.net/records/483/larkin-community-hospital-irb/75f52ff6-6253-4542-8aad-5f4398672c6c)

## Related Officers

- [Chantae D. Mitchell](https://www.globalkeysolutions.net/people/chantae-d-mitchell/0da68244-86f3-4119-b965-0b2dceb1c523)
- [investigator](https://www.globalkeysolutions.net/people/emily-a-baldwin/92d70174-7029-44f4-af30-e3230d4e9507)

Company: https://www.globalkeysolutions.net/companies/larkin-community-hospital-irb/98a77c41-6a36-407b-9d39-df4511f274e7

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9