FDA EIR - Steris - November 15, 2016

An FDA comprehensive surveillance inspection was conducted at Steris Inc. (doing business as Steris AST) in Libertyville, IL, from November 7 to November 15, 2016. The inspection focused on the firm's gamma irradiation sterilizer operations, under compliance programs 7341.002 and 7341.002A, pertaining to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) and Tissue Establishments, respectively, regulated under Section 361 of the Public Health Service Act. This particular inspection did not identify any new objectionable conditions, and no Form FDA 483 (Inspectional Observations) was issued. The primary objective included verifying the corrections made in response to a previous inspection on January 27, 2015. During that prior inspection, Steris Inc. received a 3-point FDA 483 for issues including inadequate procedures for Corrective and Preventative Action (a repeat observation), insufficient Process Control procedures, and a lack of documentation for in-process inspections, tests, or other verification activities. Management had committed to addressing these observations and provided a written response. During the current inspection, the FDA investigator reviewed these responses and verified that the previously identified objectionable conditions had been adequately corrected. The firm continues to operate as a contract gamma irradiation sterilizer for various products, including medical devices, biologics, and human/animal drug products. No samples were collected, and no photographs were taken, indicating a satisfactory outcome for the 2016 inspection.