Abbott receives FDA warning letter over FreeStyle Libre CGMs

What’s happened
Abbott have received a warning letter from the U.S. Food and Drug Administration (FDA) following an inspection of its diabetes care site in Alameda, California. The letter focuses on how Abbott tests and verifies the accuracy of its FreeStyle Libre CGMs before they are released.

What the FDA found

According to the FDA, inspectors identified gaps in Abbott’s performance specifications and testing processes for Libre sensors. These included:

• Accuracy requirements were not consistently transferred to third-party manufacturers.

• Ongoing monitoring was not always in place for products during manufacture or after completion.

• Finished Libre CGMs were released without accuracy testing after final assembly, sterilisation and programming.

• Acceptance criteria and sampling plans were not statistically robust enough to ensure only compliant devices were distributed.

The FDA said relying on earlier, component-level testing does not guarantee that finished, packaged devices meet accuracy standards at the point of release.

Context
The warning letter follows a recall announced in November, when around 3 million FreeStyle Libre 3 sensors were withdrawn after Abbott identified that some devices could generate incorrect low glucose readings. Accuracy issues were a central theme in the FDA’s inspection findings.

What Abbott says
Abbott has told the FDA it is implementing corrective actions and is providing ongoing updates. However, regulators concluded that responses submitted in November and December did not yet adequately address the issues raised.

What this means for Libre users
Importantly, the warning letter does not restrict Abbott’s ability to manufacture, market or distribute FreeStyle Libre products. Analysts covering Abbott have also indicated that no further recall has been ordered and that there is no expected near-term impact on product availability or company guidance.

Abbott is also continuing development of its next-generation dual-analyte sensor, designed to measure both glucose and ketones, which the company still expects to launch this year.

See copy of the FDA letter here

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What CGM is not associated or affiliated with Abbott or FreeStyle Libre. Content here and on our websitewww.whatcgm.com does not constitute medical advice or replace the relationship between you and healthcare professionals nor the advice you receive from them.

The author of this blog has type 1 diabetes and uses a CGM on NHS prescription.