483
Isomedix Operations, Inc.FDA 483 - Isomedix Operations, Inc. - October 29, 2018
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Record Details
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.
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ID · 3928f2a8-8ce4-41e4-a407-67b01be6a26c