Ascent Pharmaceuticals Inc – FDA 483, Oct 13, 2020

Ascent Pharmaceuticals, Inc. in Central Islip, NY, was inspected and cited for significant deficiencies in data integrity, quality system procedures, and storage conditions. Observations included a lack of audit trail review for laboratory and manufacturing equipment, premature closure of change controls, and inadequate investigation and effectiveness checks for CAPAs. Additionally, drug product components were stored without proper humidity control.