FDA 483 - Ingenus Pharmaceuticals NJ, LLC. - December 14, 2017

Ingenus Pharmaceuticals NJ, LLC in Fairfield, NJ, a drug manufacturer, was inspected by the FDA from December 11-14, 2017. The inspection revealed significant deficiencies in laboratory controls, including improper handling of Out of Specification results, inadequate verification of standard solutions, and the use of test equipment that did not meet specifications. These issues indicate a lack of adherence to quality control procedures for drug product release.