Noven Pharmaceuticals Inc – FDA 483, Nov 17, 2021

Noven Pharmaceuticals Inc., a transdermal drug manufacturer in Miami, FL, was cited for four observations during an FDA inspection. The observations highlight significant issues with environmental controls, sanitation procedures, the thoroughness of investigations into discrepancies, and the review of batch records and equipment calibration. These findings indicate a need for improved quality system oversight and adherence to GMPs.