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 ...

The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.

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 ...

We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of the factories that made them.

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 ...

In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...

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 ...

FILE - A sign at an Abbott Laboratories campus facility is displayed, April 28, 2016, in Lake Forest, Ill. A report released on Thursday, June 13, 2024, says the U.S. Food and Drug Administration took ...

WASHINGTON D.C., DC — 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 ...

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 ...