FDA 483 - Abbott Diabetes Care, Inc. - October 23, 2025

Abbott Diabetes Care, Inc. in Alameda, CA, was cited for two significant issues during an FDA inspection. The firm failed to adequately establish design transfer procedures for a glucose monitoring device, potentially leading to the release of non-conforming products. Additionally, the company did not submit Medical Device Reports (MDRs) within 30 days due to flawed internal criteria that excluded many potentially reportable malfunctions from being reported.