FDA 483 - InvaGen Pharmaceuticals, Inc. - December 19, 2018

InvaGen Pharmaceuticals, Inc. in Central Islip, NY, was inspected by the FDA from December 10-19, 2018, resulting in a Form 483 with three observations. The inspection revealed significant issues including the failure to quarantine incoming active pharmaceutical ingredients, inadequate statistical procedures for in-process sampling, and deficiencies in the routine calibration program for critical equipment. These observations indicate a need for improved quality control and manufacturing practices at the facility.