FDA demands better response from Abbott over Libre inspection violations

 Abbott has been hit with a slew of complaints from the FDA in a warning letter related to its continuous glucose monitor (CGM) franchise, FreeStyle Libre.

Last October, an agency inspection of Abbott's diabetes care division in Alameda, California, “revealed that these devices are adulterated,” the FDA said in a warning letter dated Jan. 23 and added to its website Feb. 3. The agency took issue with Abbott's practices surrounding the “manufacture, packing, storage, or installation” of the products.

Abbott responded in November and December of last year, but the warning letter contends the company's responses were “inadequate.”

The FDA originally said Abbott did not give specific glucose sensor accuracy requirements to third-party manufacturers. Abbott was also accused of failing to ensure proper monitoring of products that are either in the manufacturing process or finished.

“We reviewed your firm’s responses and conclude that they are not adequate,” the FDA wrote in its warning letter. 

The company's proposed “interim monitoring activities and proposed future testing” wouldn't ensure that the devices can meet “validated accuracy performance requirements,” the FDA said.

Abbott must “take prompt action to address any violations identified in this letter,” the FDA added.

Abbott said in a statement to Fierce MedTech that it is "committed to maintaining the highest standards of quality and reliability for people living with diabetes who depend on our technology every day. We take this matter seriously and are working diligently to address the FDA’s observations."  

Back in November, Abbott launched an effort to replace some of its FreeStyle Libre 3 CGMs—following reports of hundreds of injuries and seven deaths worldwide—after some sensors showed they may provide incorrect readings that could prompt users to skip insulin doses. 

Last month, Abbott’s full-year and fourth-quarter results saw its nutrition and diagnostics units drag on sales as the medtech continues to try to escape the headwinds from a China downturn, a post-COVID sales slump and the loss of a government contract for its nutrition business.

https://www.fiercebiotech.com/medtech/abbott-hit-quality-violations-fda-over-freestyle-libre-cgm-products