FDA 483 - Saptalis Pharmaceuticals LLC - March 06, 2026

An FDA inspection of Saptalis Pharmaceuticals LLC in Hauppauge, NY, a manufacturer of drug products, revealed significant deficiencies in equipment design and maintenance. Specifically, the firm failed to establish appropriate controls for the cleaning and reuse of transfer hoses, including a lack of replacement intervals, leachable studies, and written procedures. These issues indicate a potential risk to product quality and compliance with manufacturing standards.