Loading…
Visgeneer, Inc. manufactures the eBchek Blood Glucose Monitoring System and eBuricacid/Uritouch Blood Uric Acid Monitoring System, which the FDA determined are medical devices subject to quality system regulations. During a February 2025 inspection at the company's Taiwan facility, the FDA found the eBchek system was adulterated because manufacturing controls failed to comply with current good manufacturing practices (CGMP) under 21 CFR Part 820, specifically including failure to adequately establish and maintain procedures for validating device design—notably, the design was not validated using initial production units with documented parts, software versions, or production dates. The company submitted a response to the FDA 483 inspection observations on March 13, 2025, but the violations identified remained unresolved.