483
Stephen Fallon PhDStephen Fallon PhD – FDA 483, Jun 13, 2025
Record Details
An FDA inspection of Stephen J. Fallon PHD, a clinical investigator in Wilton Manors, FL, revealed significant deficiencies in the documentation of informed consent for a clinical study. The primary finding was that informed consent forms were not properly signed or dated by subjects or their legally authorized representatives, and in one instance, consent was not obtained prior to screening activities.
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ID · 1b0cb226-e829-4e92-aab4-194806aabd3a
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