FDA 483 - Isomedix Operations Inc. - April 12, 2022

During an inspection, Isomedix Operations Inc. in Chester, NY, an E-Beam Contract Sterilizer, was cited for inadequate procedures to control nonconforming product. The firm failed to issue nonconformity reports for out-of-specification E-beam dose verifications and allowed customers to incorrectly complete nonconformity reports with missing or conflicting final dispositions. These issues indicate a significant breakdown in quality control processes for irradiated products.