FDA 483 - Guardian Drug Co. Inc. - February 17, 2022

An FDA inspection of Guardian Drug Co. Inc. in Dayton, NJ, a drug manufacturer, revealed significant deficiencies across multiple areas. The firm was cited for inadequate laboratory controls, failure to thoroughly investigate out-of-specification results, insufficient quality unit review of production records, and unvalidated equipment cleaning procedures. These issues indicate a lack of robust quality systems necessary to ensure drug product quality and purity.