FDA 483 - Quagen Pharma, LLC - November 08, 2019

Quagen Pharma, LLC in West Caldwell, NJ, was inspected for a Pre-Approval Inspection (PAI) related to Cyproheptadine Hydrochloride Tablets, USP 4mg. The inspection revealed significant deficiencies in quality control, including inadequate Out of Specification (OOS) investigations, insufficient cleaning validation procedures for equipment, and a failure of the quality unit to ensure comprehensive employee training on critical Standard Operating Procedures. These issues indicate a lack of robust quality systems and control over manufacturing processes.