FDA 483 - Accupac, Llc - November 18, 2021

Accupac, Llc in Lakewood, NJ was inspected by the FDA from October 21 to November 18, 2021, resulting in two observations. The inspection revealed issues with laboratory documentation practices, where GMP data was recorded on uncontrolled personal notepads, and a failure of the quality control unit to properly qualify a secondary reference supplier for OTC drug products. These findings indicate deficiencies in the firm's adherence to good documentation practices and quality control procedures.