483
Larkin Community Hospital IRBLarkin Community Hospital IRB – FDA 483, Nov 19, 2021
Record Details
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.
View Company Profile
ID · 75f52ff6-6253-4542-8aad-5f4398672c6c
Other documents for Larkin Community Hospital IRB
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.