FDA 483 - Aurolife Pharma, LLC - December 07, 2021

An FDA inspection of AuroLife Pharma, LLC in Dayton, NJ, revealed significant deficiencies in data integrity, quality control unit procedures, and facility maintenance, including persistent water leaks. The inspection also cited inadequate laboratory controls, unvalidated test methods, and insufficient equipment cleaning protocols, indicating a broad failure to adhere to cGMP regulations. Several observations were repeats from a previous 483, highlighting a lack of effective corrective actions.