# FDA 483 - Larkin Community Hospital IRB - November 19, 2021

Source: https://www.globalkeysolutions.net/records/483/larkin-community-hospital-irb/75f52ff6-6253-4542-8aad-5f4398672c6c

> FDA 483 for Larkin Community Hospital IRB on November 19, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Larkin Community Hospital IRB
- Inspection Date: 2021-11-19
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Larkin Community Hospital IRB in South Miami, FL, was cited for multiple deficiencies related to its Institutional Review Board operations. The inspection revealed issues with IRB meeting composition, inadequate record-keeping for continuing reviews and study approvals, and incomplete informed consent documents. These observations indicate significant non-compliance with regulatory requirements for human subject protection and IRB oversight.

## Related Documents

- [483 - 2025-05-21](https://www.globalkeysolutions.net/records/483/larkin-community-hospital-irb/0e344049-890a-4411-9980-08905294cfb3)

## Related Officers

- [Richard A. Lyght](https://www.globalkeysolutions.net/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

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

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6