Dive Brief:
- Abbott received a warning letter from the Food and Drug Administration related to its FreeStyle Libre continuous glucose monitors.
- The warning letter, dated Jan. 23 and posted to the FDA’s website on Tuesday, concerns performance specifications and testing for the glucose sensors’ accuracy. An Abbott spokesperson wrote in an email that the company is implementing corrective actions and providing ongoing updates to the FDA.
- The warning letter does not affect Abbott’s ability to manufacture, market or distribute Libre products, wrote Leerink Partners analyst Mike Kratky and J.P. Morgan analyst Robbie Marcus.
Dive Insight:
In November, Abbott recalled about 3 million FreeStyle Libre 3 sensors after finding that some devices may provide incorrect low glucose readings. Accuracy issues were also the focus of the warning letter.
Abbott received the warning letter after an inspection of its diabetes care site in Alameda, California, from Oct. 14 to Oct. 23. Warning letters are used by the FDA to bring companies into compliance after identifying significant violations.
Inspectors found that Abbott did not transfer specific glucose sensor accuracy requirements to third-party manufacturers, and did not ensure ongoing monitoring of products that are in process or finished. Abbott responded to these concerns in November and December, but the FDA determined that the firm’s responses were inadequate.
The FDA said its inspection showed that Abbott released finished FreeStyle Libre CGMs without first testing them for accuracy after they had been fully assembled, sterilized and programmed.
“Reliance on upstream, component-level testing performed prior to critical manufacturing steps does not ensure that finished, sterilized, and packaged devices meet accuracy performance requirements at the time of release,” the warning letter stated.
The agency said Abbott failed to establish statistically valid acceptance criteria and sampling plans to ensure that only conforming finished devices are distributed.
Kratky wrote in a note to clients Tuesday that the warning letter does not require a product recall, and Abbott still expects to launch its dual analyte sensor this year. Abbott has been developing a CGM that can track glucose and ketone levels for people with diabetes.
Marcus wrote in a research note that “Abbott is working to implement corrective actions in a timely manner, and with what we know so far, we don’t expect any material impact to numbers.”
