FDA 483 - Saptalis Pharmaceuticals LLC - October 30, 2018

Saptalis Pharmaceuticals, LLC, a pharmaceutical drug manufacturer in Hauppauge, NY, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written procedures and validation studies for equipment cleaning, inadequate warehousing procedures with missing temperature mapping, and unestablished accuracy and reproducibility for a critical test method. These issues indicate a failure to ensure product quality and compliance with cGMP regulations.