FDA 483 - Isomedix Operations Inc. - November 07, 2019

An FDA inspection of Isomedix Operations Inc., a contract sterilizer in Chester, NY, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for the control of in-process medical device products, leading to potential mix-ups and incorrect processing. Additionally, the inspection found that the company did not maintain required distribution records for a medical device product.