DexCom falls after warning letter from FDA related to quality concerns
Arizona related to concerns about manufacturing processes and quality management systems. The FDA cited issues with DexCom’s ...
DexCom Gets FDA Warning Letter After Inspections of Facilities
In the letter the FDA mentioned non-conformities in manufacturing processes and the quality management system, the company ...
DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letter
DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.
Yahoo Finance1mon
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities ... containing "observations" that FDA inspectors "deem to be objectionable." ...
Business Insider1mon
DexCom receives warning letter from FDA, sees no impact to FY25 guidance
In the warning letter, the FDA cited deficiencies in the response ... non-conformities in manufacturing processes and quality management system. The warning letter does not restrict the company ...
The Manila Times9d
Viva Biotech's Wholly-Owned Subsidiary Langhua Pharmaceutical Successfully Passes U.S. FDA On-Site Inspection
Zhejiang Langhua Pharmaceutical Co., Ltd. ('Langhua Pharmaceutical'), a wholly-owned subsidiary of Viva Biotech Holdings ('Viva Biotech'), underwent a cGMP (Current Good Manufacturing Practices) ...