Acino Products, LLC – FDA 483, Jun 12, 2019

Acino Products, LLC in Hamilton, NJ, received a Form FDA 483 with seven observations following an inspection from May 28 to June 12, 2019. The inspection revealed significant deficiencies in quality control, facility maintenance, equipment cleaning, process validation, and laboratory controls, many of which were repeat observations from a previous inspection. These issues indicate a systemic failure to maintain adequate control over drug product manufacturing and quality.