FDA 483 - LIPIDCHEM SDN BHD - December 04, 2017

An FDA inspection of Lipidchem Sdn Bhd, a food ingredient and additive manufacturer in Masai, Malaysia, revealed significant deficiencies in preventative controls and equipment maintenance. Observations included inadequate process control parameters for metal detectors, a lack of review of control records by a preventative controls qualified individual, and poorly designed and maintained equipment with heavily pitted tanks, posing a contamination risk. These issues indicate a failure to ensure food safety and product quality.