A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

In the letter the FDA mentioned non-conformities in manufacturing processes and the quality management system, the company ...

DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.

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." ...

Zhejiang Langhua Pharmaceutical Co., Ltd. ('Langhua Pharmaceutical'), a wholly-owned subsidiary of Viva Biotech Holdings ('Viva Biotech'), underwent a cGMP (Current Good Manufacturing Practices) ...