483
Manuel F. Fernandez, M.D.Manuel F. Fernandez, M.D. – FDA 483, Feb 17, 2023
Record Details
Manuel F. Fernandez, M.D. in Miami, FL, received an FDA Form 483 for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. The inspection revealed that four subjects were randomized and received investigational product despite not meeting the protocol's inclusion criteria. Additionally, one subject's pre-visit diaries did not meet the specified inclusion criteria.
View Company Profile
ID · 5b863606-8f64-4260-b980-5a981b15dfbe
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.