Raritan Pharmaceuticals, Inc. – FDA 483, Apr 2, 2025

Raritan Pharmaceuticals, Inc. in East Brunswick, NJ, was cited for significant deficiencies in their manufacturing and quality control processes for OTC drug products. The inspection revealed a lack of impurity and microbial testing for released products, inadequate sampling of high-risk components, and insufficient cleaning and process validation procedures. Additionally, the firm's training program for analysts was found to be ineffective, contributing to a high number of unresolved Out-of-Specification investigations.