FDA 483 - Isomedix Operations, Inc. - October 29, 2018

An FDA inspection of Isomedix Operations, Inc. in Whippany, NJ, from October 23-29, 2018, identified one observation related to facility and equipment systems. The firm was cited for not maintaining written records of major equipment maintenance and use in individual equipment logs. This indicates a minor deficiency in record-keeping practices for critical equipment.