FDA 483 - Isomedix Operations, Inc. - January 27, 2026

Isomedix Operations, Inc. in Libertyville, IL, received an FDA Form 483 for deficiencies related to the storage and handling of HCT/Ps. The inspection revealed failures in recording and maintaining storage temperatures, establishing adequate procedures for HCT/P storage, and documenting equipment maintenance. These observations indicate a lack of control over critical processes and environmental conditions.