FDA EIR - Steris Laboratories - September 22, 2017

An FDA inspection was conducted at STERIS Laboratories, Inc. in Brooklyn Park, MN, from September 21 to September 22, 2017. The inspection focused on the company's role as a contract sterilizer and packager for Class I and Class II medical devices. This Level II comprehensive inspection followed Compliance Program 7382.845 for Medical Device Manufacturers and utilized the Quality System Inspectional Technique (QSIT). Key areas examined included Management Controls, Corrective and Preventive Actions (CAPA), Complaint handling, and Production and Process Controls.

Crucially, the inspection identified no significant deviations or issues. No FDA-483, Inspectional Observations, were issued to STERIS Laboratories, Inc., indicating compliance with regulatory requirements. Consequently, no specific violations were cited, and no required actions were mandated by the FDA. The report confirms that the firm was operating in adherence to the relevant regulatory frameworks, aligning with the outcomes of previous inspections that also resulted in no observations.