The FDA cited a skincare product manufacturer in a warning letter for significant violations of cGMP for finished drugs and APIs, along with several…

Novartis has withdrawn its applications for a biosimilar of Amgen’s blockbuster drug Neulasta after regulators in Europe raised questions about its…

A Brazilian antibiotics maker that was hammered in an FDA warning letter issued last month also caught the attention of the European Medicines Agency, which…

The FDA has savaged U.K.-based Porton Biopharma in a warning letter for repeated contamination of batches of Erwinaze.

India’s Hetero Labs has been slapped with an FDA Form 483 for some dubious practices at a formulations manufacturing plant in Jadcherla.

Japan’s Eisai, which has reduced its manufacturing operations in the U.S., is now facing regulatory concerns for a plant in Baltimore.

Germany’s B. Braun has run afoul of regulators in Europe after an inspection last week of a warehouse in the Czech Republic found it was distributing products…

Despite great strides in oversight of foreign manufacturers, the FDA still has a huge backlog of foreign plants that have never been seen and is struggling to…

Drug wholesaler McKesson will pay $150 million to settle with the Justice Department allegations that it did not monitor "suspicious" opioid orders…

Regulatory