FDA 483 - Novitium Pharma LLC - July 08, 2021

An FDA inspection of Novitium Pharma LLC in East Windsor, NJ, a drug manufacturer, revealed a significant issue regarding the adherence to written procedures for in-process controls. Specifically, the firm failed to follow established protocols for collecting stratified samples for Content Uniformity testing of exhibit batches, leading to inadequate documentation of sample collection times and signatures. This indicates a lapse in quality control and record-keeping practices for drug product manufacturing.