FDA EIR - Novitium Pharma LLC - February 04, 2019

An FDA inspection of Novitium Pharma LLC, located in East Windsor, NJ, was conducted from January 23 to February 4, 2019. This was the company's initial general Current Good Manufacturing Practice (cGMP) inspection, following established FDA guidelines for drug manufacturing. The inspection covered critical operational systems including Quality, Laboratory, Facilities, Production, Packaging and Labeling, and Material Systems. The inspection identified several deficiencies, resulting in an FDA-483 form with observations. Key issues included inadequate assessment and control of changes to approved drug applications by the quality unit, incomplete laboratory records for testing and standardization of reference standards, and a lack of written and fully followed procedures for the quality control unit. Further verbal observations highlighted the absence of control procedures to validate manufacturing processes, deficient procedures for managing drug product quality risks, inadequate control over electronic records (specifically unreviewed audit trails and reporting functions), and unjustified deviations from written test procedures. In response to the findings, Novitium Pharma LLC's management acknowledged the observations at the closeout meeting and committed to implementing necessary corrections, providing a written response within 15 days. Additional records were also supplied to the inspectors during the closeout discussions.