The FDA has taken steps against a Chinese heparin maker it says is using potentially tainted raw supplies and which refused to let inspectors get a good look at its plants or records so that it could find out for sure.
A loose hair has again tripped up Hospira, which is voluntarily recalling one lot of heparin as a result.
The U.S. has banned some Chinese heparin manufacturers and warned drugmakers to make sure their supplies meet FDA expectations. But now Smithfield Foods' deal to sell itself to China's Shuanghui International has run up a red flag among lawmakers about heparin flowing in the other direction.
Hot off a scandal in which gelatinmakers that feed the drug capsule industry were found to be using industrial, not food-grade, product, China is imposing new rules on drug manufacturers to audit excipient suppliers.
The FDA is again soliciting 100 foreign API makers for a pilot program intended to help allow them to import products faster if they agree to meet certain manufacturing and supply chain standards. The idea is that if the agency has API companies it knows it can trust, it can focus more resources on those that it can't.
Illustrating the regulatory challenges emanating from drug manufacturing in China, authorities there have recalled 13 medications filled in capsules believed to contain excessive amounts of chromium.
New details about problems with the production of heparin and other drugs by APP Pharmaceuticals ($APPX) have been released by the Food and Drug Administration on its website.
APP Pharmaceuticals ($APPX) has had its production of heparin called into question in an FDA warning letter and has been ordered to present three years worth of out-of-specification results for...
The contaminated heparin saga continues. The FDA has put 14 more Chinese suppliers that made a tainted ingredient for creating the widely used blood thinner on a watch list, and U.S. regulators are...
Facing an ongoing House investigation over the tainted heparin episode, the FDA has identified another 14 Chinese companies that supplied contaminated materials to drugmakers. This brings to 22 the...