FDA 483 - Pharmaceutical Innovations, Inc. - June 19, 2017

Pharmaceutical Innovations, Inc. in Newark, NJ, was inspected by the FDA from May 15 to June 19, 2017, revealing significant quality system deficiencies. The firm lacked established procedures for corrective and preventive actions, design control, process validation, and acceptance activities. These issues indicate a systemic failure to ensure product quality and compliance with regulatory requirements for medical device manufacturing.