FDA 483 - Seaway Pharma Inc. - June 18, 2025

Seaway Pharma Inc. in Massena, NY, was cited for multiple significant deficiencies during an FDA inspection from May 19 to June 18, 2025. Observations included failures in quality control unit oversight, inadequate laboratory testing and record-keeping, and poor facility sanitation. The firm also lacked proper process validation and controls to ensure drug product identity, strength, purity, and quality.