Sterigenics US, LLC – FDA 483, Aug 23, 2022

Sterigenics US, LLC in Fort Worth, TX, a contract sterilizer, was cited for significant quality system deficiencies during an FDA inspection. Observations included failing to record and justify deviations from test procedures, a quality control unit that did not timely complete investigations or close CAPAs, and a failure to follow procedures for handling customer complaints regarding drug products. These issues indicate a lack of adherence to established quality control and complaint handling processes.