Abbott Diabetes Care, Inc.

Warning LetterOpen

Christopher Scoggins Executive Vice President of Diabetes Care Abbott Diabetes Care, Inc. 1360 S Loop Rd Alameda , CA 94502-7000 United States (b)(4)FEI 3002803444Issued Jan 23, 2026Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002803444.

Violations7

Issue DateJan 23, 2026

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Abbott Diabetes Care, Inc.
Location: Christopher Scoggins Executive Vice President of Diabetes Care Abbott Diabetes Care, Inc. 1360 S Loop Rd Alameda , CA 94502-7000 United States (b)(4)
FEI Number: 3002803444
Country: United States
Issue Date: January 23, 2026
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Abbott Diabetes Care, Inc. FDA Warning Letter, January 23, 2026