483
Isomedix Operations Inc.Isomedix Operations Inc. – FDA 483, Apr 12, 2022
Record Details
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.
View Company Profile
ID · 903ea820-b74d-453f-8dc5-ea7f209abfbe
Other documents for Isomedix Operations Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.