FDA EIR - Nortech Systems, Inc. - April 02, 2018

An FDA inspection of Nortech Systems, Inc. (NSI), a contract manufacturer of Class I and II medical devices, was conducted from March 20 to April 2, 2018, at its Milaca, MN facility. The inspection, guided by Compliance Program 7382.845 and Quality System Inspectional Technique (QSIT), focused on Corrective and Preventive Action (CAPA) and Complaint handling systems, along with production controls and Medical Device Reports.

The inspection identified two significant observations, detailed in an FDA-483 form. Firstly, Nortech's CAPA procedures were found inadequate. Multiple CAPAs lacked timely follow-up and verification within the prescribed 30-90 day window after implementation, or remained open without resolution. Some closed CAPAs also exceeded this timeframe without explanation, indicating a systemic issue stemming from insufficient quality staffing.

Secondly, complaint handling procedures were not adequately established. The complaint log showed inconsistent and untimely closures, with several complaints taking 5 to 9 months to close. The existing procedure lacked explicit criteria for considering a complaint closed or a defined process for timely resolution.

Management acknowledged these findings and committed to corrective actions. They presented a CAPA remediation schedule and implemented a revised CAPA procedure during the inspection. Additionally, a draft global complaint procedure was provided, indicating proactive efforts towards quality system improvement, with a commitment to include more specific details on complaint closure timelines. The company was reminded of its responsibility to maintain its quality system.