DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San ...

It doesn’t require the recall of any products either. In the letter the FDA mentioned non-conformities in manufacturing ...

Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

The adoption of a quality management system (QMS) should be a strategic decision of a Nuclear Medicine service. Its design and implementation will be influenced by various factors, for example the ...

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." ...

Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has ...

Symbiosis Pharmaceutical Services has completed the latest inspection by the U.S. FDA of its facilities in Scotland.

and Mesa, Ariz. related to concerns about manufacturing processes and quality management systems. The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 ...