483
Eric Hollander MDFDA 483 - Eric Hollander MD - October 20, 2020
Discuss this record with AI
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.
Record Details
An FDA inspection of Eric Hollander MD in Bronx, NY, revealed a significant issue regarding the conduct of an investigational plan. The firm failed to document phone call interviews and questionnaires used to evaluate patients for signs and symptoms of infection, affecting all six subjects in a study's Open Label Extension phase. This indicates a lack of adherence to study protocols and proper record-keeping.
Open in Dashboard
ID · d8149a1a-f617-4c47-80dd-5330f132629d