FDA 483 - Paramesh Banerji Life Sciences, LLC - September 24, 2021

An FDA inspection of Paramesh Banerji Life Sciences, LLC, a homeopathic drug manufacturer in North Brunswick, NJ, revealed significant deficiencies. The firm lacked a quality control unit, written procedures for critical processes, and appropriate temperature and humidity controls for drug product storage. This included a repeat observation regarding the absence of a quality control unit.