Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous glucose monitor maker’s facilities last year.
In a filing with the SEC, the company said the March 4 letter was related to an evaluation of its San Diego headquarters, which took place last October and November, as well as its Mesa, Arizona production site that June—over “non-conformities in manufacturing processes and quality management system.”
The warning—which sent Dexcom’s stock down about 7% in aftermarket trading over the weekend, to about $73.50—comes after the company’s relocation of its manufacturing base from Southern California to Arizona.
Dexcom laid off more than 500 workers in San Diego last summer as it aims to transform its HQ into an R&D-focused center, while planning to expand the production of its G6 and G7 diabetes blood sugar trackers in the greater Phoenix area.
The new admonition came after the FDA found deficiencies in Dexcom’s response to the inspections’ official list of observations, known as a Form 483. According to the agency, some of those findings included inadequate procedures for tracking design changes, as well as design validation and risk analyses.
Dexcom said it has “already submitted several responses to the Form 483,” and is preparing a new written response to the warning letter. It will also continue to make corrective actions and pledged to provide regular updates to the agency.
The company also said it does not expect the warning letter to impact its bottom line or financial guidance—it does not restrict its ability to do business, nor does it require a recall of any products. Meanwhile, the 15-day version of Dexcom's G7 CGM is currently undergoing FDA review.