Dexcom
(Nasdaq: DXCM)
faces regulatory scrutiny in the U.S. following inspections of sites in California and Arizona.
Our sister site, Drug Delivery Business News, reports today that the company received a warning letter from the FDA.
The letter followed inspections of the company’s plants in San Diego and Mesa, Arizona. San Diego is where Dexcom’s headquarters is located, while the company last year decided to move manufacturing out of San Diego to the Mesa site. It cites deficiencies in response letters sent by Dexcom to the FDA following observations made by the agency.
According to a Dexcom SEC filing, the warning letter describes observed non-conformities in manufacturing processes and quality management systems.
BTIG analysts say they spoke with Dexcom investor relations, who say the company already implemented process controls three months ago in response to the FDA’s warning. Management didn’t reiterate its margin guidance as the company awaits more information from the FDA. However, they don’t expect changes in those metrics, either.
As of Monday, March 10, DXCM shares were down more than 15% from the week before, trading around $72 apiece.
Get the full story at our sister site, Drug Delivery Business News.
