FDA 483 - Kutol Products Company, Inc. - March 03, 2020

Kutol Products Co, a contract manufacturer in Sharonville, OH, received a Form 483 with seven observations during an inspection from February 20 to March 3, 2020. The inspection revealed significant deficiencies in quality systems, including repeat observations from 2015 regarding process validation and cleaning procedures for OTC antibacterial products. Other issues included inadequate investigations into micro deviations, poor equipment maintenance, insufficient employee training, improper component storage, and failure to follow complaint handling procedures.