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 ...

This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effe ...

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 ...

Dan O’Leary President at Ombu Enterprises, LLC recently shared with me the hangman paradox as it relates to FDA audits. For those of you who haven’t taken a course in epistemology lately, here is the ...

HerbsForever of California recalled Hingwastik Churna powder. Hingwastika extract and Gastro Care, which were sold nationwide online.

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 ...

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 ...

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This is an archived article and the information in the article may be outdated.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 ...