Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistFlextronics America LLC, a contract manufacturer of the Freestyle Libre 3 Continuous Glucose Monitor, failed to comply with FDA's Quality System Regulation (21 CFR Part 820) for medical device manufacturing. During an October 2025 inspection, the FDA identified failures to adequately validate manufacturing processes that could not be fully verified by subsequent inspection and testing, specifically involving the assembly and movement of printed circuit board assemblies (PCBAs) in puck assembly operations where process parameters directly affect the final product. The company's responses to the FDA 483 observations dated November and December 2025 were found to be inadequate in addressing these compliance gaps.