FDA EIR - Benchmark Electronics, Inc. - July 17, 2007

An FDA surveillance inspection was conducted at Benchmark Winona (formerly Pemstar, Inc.), a medical device contract manufacturer, on July 17, 2007. The facility, located in Rochester, MN, specialized in manufacturing and reprocessing electronics and printed circuit boards for medical devices, with products also including Glucose Oxidase and Glucose. The inspection occurred during a period of significant operational change, as the facility was in the process of closing and relocating its activities to other plants following its acquisition by Benchmark Electronics, Inc. in January 2007. Given this context, the inspection was abbreviated. The regulatory framework for this inspection falls under the U.S. Food and Drug Administration's oversight of medical device manufacturing. The inspection concluded with a "No Action Indicated" (NAI) classification, indicating that no significant issues or violations were identified, and consequently, no FDA Form 483 was issued. The primary required action for the FDA was to verify the plant's closure. Benchmark Winona's Director of Regulatory and Quality System pledged to keep the district office informed of the closure's status, and no further inspections are deemed necessary for this specific location.