FDA 483 - Liquipak Corp. - November 01, 2018

An FDA inspection of Liquipak Corp. in Alma, MI, a manufacturer of Tichenor's Toothpaste, revealed two significant observations. The firm's quality control unit failed to follow its own change control procedures by not reviewing and approving a job setup specification. Additionally, the company did not perform routine mechanical equipment inspections according to a written program, specifically lacking documentation for packaging machine validation.