Plexus Corporation – FDA EIR, Apr 13, 2018

An FDA inspection of Plexus Corporation's Buffalo Grove, IL facility was conducted from April 9-13, 2018. This routine inspection, guided by the Compliance Program for Medical Device Manufacturers and the Quality System Inspection Technique (QSIT) Manual, focused on the company's management, production, process controls, and particularly its Corrective and Preventive Action (CAPA) systems. The primary violations identified concerned inadequacies within Plexus Corporation's CAPA system. The company received an FDA Form 483 detailing failures to adequately document corrective and preventive action activities and their results. Specific issues included insufficient objective evidence for effectiveness checks, missing required approvals for verifications, and incomplete customer response fields in several CAPA records. A non-printing observation also highlighted typographical errors in CAPA problem identification, indicating a lack of thorough review. These deficiencies suggest non-compliance with the regulatory framework outlined in 21 CFR 820.100(b) for Corrective and Preventive Action and 21 CFR 820.40(a) for document control. Plexus Corporation management committed to correcting these procedural issues, approving necessary resources, and providing a written response to the FDA within 15 business days, outlining their global systemic corrections. This facility contract manufactures Class I, II, and III medical devices.