FDA 483 - Serim Research Corporation - July 30, 2025

An FDA inspection of Serim Research Corporation in Elkhart, IN, a medical device manufacturer, revealed significant deficiencies in its quality management system. The firm was cited for inadequate risk analysis, statistically unsound sampling plans for finished goods, and a lack of established procedures for equipment calibration and maintenance. Additionally, the company failed to adequately address underperforming suppliers according to its own procedures.