FDA 483 - Steven C. Kester, M.D. - May 27, 2022
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.
The FDA inspected Clinical Research Center of Florida & Urology Center of Florida in Pompano Beach, FL, and identified significant deficiencies in their conduct of clinical studies. The firm failed to maintain adequate and accurate case histories, evidenced by missing source documents and numerous time inconsistencies in study records. Additionally, the inspection revealed a failure to obtain proper informed consent from human subjects before performing study-related procedures.
ID · 14980489-0670-43ee-ab92-07ee26adcc96