INNOVATION LABS, INC. – FDA 483, Jul 5, 2022

Innovation Labs, Inc. in Mahwah, NJ, an OTC drug manufacturer, was cited for significant deficiencies during an FDA inspection from June 21 to July 5, 2022. Observations included a lack of written quality control procedures, inadequate production and process controls, unsanitary building conditions, and malfunctioning equipment. These issues indicate a general lack of control over manufacturing processes and quality assurance.