Our sister site Drug Delivery Business News, reports today that the FDA issued the letter on Jan. 23 and made it public today, Feb. 3. It relates to an inspection of Abbott’s Alameda, California, facility from Oct. 14, 2025, through Oct. 23, 2025.
According to the letter, the inspection found that the company’s FreeStyle Libre continuous glucose monitors (CGMs) produced at the facility are “adulterated” in that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements.”
The FDA alleged four violations against Abbott. Abbott responded to the FDA’s claims on Nov. 14, 2025, and Dec. 19, 2025. However, the FDA deemed its responses to the alleged violations “inadequate.”
Dexcom, Abbott’s chief rival in the CGM market, faced a similar warning letter last year related to its own manufacturing practices.
The letter also comes a few months after Abbott issued a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S. The correction came as a result of an issue that led to hundreds of severe adverse events, including seven deaths.
Statement from an Abbott spokesperson
“Abbott received a warning letter from the U.S. FDA related to an inspection at its diabetes care site in Alameda, California, in October 2025. We’re 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.”
Get the full story at our sister site, Drug Delivery Business News.
