On March 20, 2025, the U.S. Food and Drug Administration (FDA) announced its intention to extend the compliance date for the ...

The U.S. Food and Drug Administration has launched the "Chemical Contaminants Transparency Tool" (CCT Tool), an online ...

With the increasing demand for advanced manufacturing solutions that meet global regulatory requirements, the availability of InstantGMP PRO™ in Spanish ensures that manufacturers can efficiently ...

Compliance is a critical aspect of running a successful business. Whether you operate in finance, healthcare, technology, or ...

A former commissioner of the Food and Drug Administration says it is vital to invest in ensuring infant formula and breast milk banks are inspected rigorously.

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

Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last ...

DexCom DXCM received a warning letter from the FDA on March 4, 2025, following inspections of its San Diego and Mesa facilities in 2024. The FDA cited deficiencies in the company’s manufacturing ...

I3CGlobal FDA INSPECTION BANGALORE, INDIA, March 14, 2025 /EINPresswire / -- Indian pharmaceutical, nutraceutical, and medical devic ...

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

After years of concerns that pulse oximeters may provide less accurate results for people with dark skin pigmentation, the Food and Drug Administration issued a draft guidance in January clarifying ...

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 ...