483
Jose D. Gutierrez, MD, MPHFDA 483 - Jose D. Gutierrez, MD, MPH - January 10, 2025
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An FDA inspection of Columbia University Irving Medical Center in New York identified significant deficiencies in the conduct of clinical investigations. The firm failed to submit required annual IND reports, adequately monitor ongoing investigations, and maintain complete case histories for study subjects. Additionally, the inspection revealed failures in the timely reporting of serious adverse events to the sponsor.
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