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Abbott Diabetes Care, Inc. was cited for manufacturing adulterated continuous glucose monitoring devices, including the FreeStyle Libre 3, that failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The company did not adequately establish and maintain procedures to ensure device design specifications were correctly transferred to production, particularly regarding performance specifications communicated to third-party manufacturers. The violations were identified during an FDA inspection conducted in October 2025 at the company's Alameda, California facility.