FDA 483 - RK Pharma Inc. - August 28, 2025

An FDA inspection of Rx Pharma Inc., a drug product manufacturer in Pearl River, NY, revealed significant deficiencies in its quality control unit and manufacturing processes. The firm failed to adequately follow written procedures for process validation, exhibited issues with batch record documentation, and did not properly test components for purity, strength, and quality. These findings indicate a lack of adherence to Good Manufacturing Practices.