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 Finance28d
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." ...
STAT1mon
We’re reading about an FDA quality lab lease, Marty Makary’s confirmation hearing, and more
The Trump Administration reversed course on plans to terminate the lease of a major Food and Drug Administration quality lab, Endpoints News reports. The St. Louis facility was one of about 30 FDA ...
Business Insider28d
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 Times7d
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) ...
DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letter
The company noted the FDA held inspections of its San Diego, Calif., and Mesa, Ariz., facilities last year, which found "non-conformities in manufacturing processes and quality management system." ...