FDA 483 - Isomedix Operations, Inc. - September 18, 2023

Isomedix Operations Inc. in Libertyville, IL, a radiation sterilization facility, was cited for significant quality control and production process deficiencies during an FDA inspection. Observations included the improper discarding of original processing records, failure to define operational qualification intervals and perform periodic verification for gamma irradiators, and a lack of control over the issuance of electronic processing records. Additionally, the firm failed to adequately extend investigations into discrepancies, specifically regarding the use of expired verification dosimeters and their impact on released drug products.