FDA 483 - Syntho Pharmaceuticals, Inc. - September 03, 2019

Syntho Pharmaceuticals, Inc. in Farmingdale, NY, a drug manufacturer, was cited with 13 observations during an FDA inspection from July to September 2019. The inspection revealed significant deficiencies in laboratory controls, test method validation, equipment calibration, complaint handling, cleaning validation, and quality review processes, indicating a broad lack of adherence to good manufacturing practices. Repeated observations highlight persistent issues with established procedures and quality assurance for drug products like Syntest/Covaryx tablets.