FDA 483 - ALK-Abello, Inc. - March 01, 2019

An FDA inspection of AllerQuest LLC, a sterile human drug manufacturer in Plainville, CT, revealed significant deficiencies across multiple critical areas. The firm was cited for inadequate aseptic processing controls, environmental monitoring, and a failure to thoroughly investigate discrepancies and critical defects. Repeat observations from previous inspections highlight persistent issues with quality unit oversight, cleaning validation, and process validation, indicating a systemic lack of control over sterile drug product manufacturing.