FDA 483 - Acino Products, LLC - July 01, 2021

An FDA inspection of Acino Products, LLC in Hamilton, NJ, from June 15 to July 1, 2021, revealed numerous significant deficiencies in their drug manufacturing operations. The firm was cited for inadequate quality control procedures, poor facility maintenance, unqualified equipment, insufficient stability and raw material testing, and a lack of employee training. Several of these observations were repeats from prior FDA 483 inspections, indicating persistent non-compliance with cGMP regulations.