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…

The FDA has issued a warning letter to a Chinese company it found peddling active pharmaceutical ingredients it had not manufactured or tested.

Ignoring issues in a sterile manufacturing plant can lead to big problems, like the $18 million-plus Baxter International will pay to resolve a federal…

Canadian generic producer Apotex has a new recall to deal with, this time for nearly 50,000 bottles of a diuretic.

The FDA has issued a warning letter to a Wockhardt plant in India whose problems have leached into a CRL issued to U.S. biotech Cempra.

FDA concerns with manufacturing by India’s Wockhardt and Pfizer’s Hospira are one of the factors to derail the approval of a new antibiotic being developed by…

The FDA this year delayed the approval of six new drugs this year because of manufacturing matters, five of which were the subject of complete response letters…

A North Carolina company that makes transdermal patches has gotten an FDA warning letter for releasing subpotent transdermal pain patches.

Labeling issues can sometimes lead to recalls because they pose serious health threats, and sometimes because a treatment for athlete’s foot is labeled as a…

Drug Safety