FDA 483 - Senores Pharmaceuticals - March 28, 2025

Senores Pharmaceuticals in Hoschton, GA, was cited for significant delays in submitting both quarterly and annual periodic adverse drug experience reports (PADERs) for multiple approved drugs. The inspection, conducted from March 25-28, 2025, revealed numerous instances where these critical safety reports were submitted well past their regulatory deadlines, indicating a systemic issue with postmarketing surveillance compliance.