FDA 483 - MaxPax, LLC - July 25, 2019

MaxPax, LLC in Elkhorn, WI, was inspected by the FDA from July 22-25, 2019, and received six observations, many of which are repeat findings from previous inspections. The observations highlight significant deficiencies in the firm's quality control unit, manufacturing processes, equipment cleaning, process validation, raw material testing, and recordkeeping. These issues indicate a systemic failure to ensure the quality, purity, and identity of their drug products.