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." ...
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." ...
Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in ...
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