FDA 483 - Paramesh Banerji Life Sciences, LLC - August 24, 2023

Jaranesh Banerji Life Sciences, LLC, a homeopathic drug manufacturer in North Brunswick, NJ, received a Form 483 with seven observations following an FDA inspection. The firm was cited for significant deficiencies across its quality system, including the absence of a quality control unit, lack of written procedures for critical operations, inadequate employee training, and improper storage conditions for drug products. These issues indicate a severe lack of adherence to current good manufacturing practices for drug products.