Amanda Murphy, Senior Director at GlobalData, discusses how real-time intelligence can turns regulatory events into ...

A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant ...

U.S. audits of foreign country inspection systems for equivalency with America’s food safety regulations, such as the Federal Meat Inspection Act, the ...

The U.S. Food and Drug Administration (FDA) recently announced the results of its pilot program evaluating whether several third-party food safety standards align with the food safety requirements in ...

City, India, December 23, 2024: In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device manufacturers are enhancing their Good ...

The U.S. FDA inspection of the facility, Unit-II in Bhiwadi, Alwar, from November 3-14 concluded with nine observations. They are procedural in nature and will be responded to within the stipulated ...

The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide ...

In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number ...

The audit will determine if the FDA safeguarded the nation's food supply. The Health and Human Services' Office of Inspector General is launching an audit into how the Food and Drug Administration ...

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. The U.S. Food and Drug Administration took ...