FDA 483 - Seaway Pharma Inc. - July 24, 2024

An FDA inspection of Seaway Pharma Inc. in Massena, NY, revealed a significant issue with the physical plant's plumbing system. The observation noted a cross-connection risk between waste/sewage lines and water used for manufacturing dietary supplements, cleaning, or hand-washing facilities. This indicates a potential for insanitary conditions impacting product quality and safety.