FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...

FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...

The FDA approved modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy that permit patients to take a pregnancy test outside of a medical setting during and after isotretinoin treatment ...

When US Food and Drug Administration (FDA) inspectors arrived unannounced at Hetero Labs' warehouse facility in Visakhapatnam, India, on 19 September , they documented conditions that would result in ...

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of the largest employers in Lexington, has continued to face federal ...

A Johnson & Johnson innovate medicine subsidiary, Janssen Vaccines, landed in hot water with the FDA this summer over a 2024 inspection of the company’s production facility in South Korea. In a ...

The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...

Add Yahoo as a preferred source to see more of our stories on Google. Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of ...

Kemwell Biopharma Pvt Ltd ("Kemwell"), a leading global biologics Contract Development and Manufacturing Organization (CDMO), announced today that its drug-product manufacturing facility in Bengaluru ...