Morton Grove Pharmaceuticals, Inc. – FDA 483, May 20, 2021

Morton Grove Pharmaceuticals, Inc. received a Form 483 citing significant deficiencies across its quality system. Issues include inadequate investigations into recurring microbial contamination and out-of-specification results, widespread data integrity concerns in the QC laboratory, and failures in stability testing and cleaning validation. These findings indicate a lack of robust controls to ensure drug product quality and purity.