FDA Turns to Federal Agents to Seize Raw Heparin

Cincinnati, OHJust when you thought it was safe to go back in the water—or, in this case get a shot of heparin for various reasons—it has been learned that a small company in Cincinnati had contaminated heparin manufactured in China still kicking around its facility almost a year after the heparin scare first broke.

The US Food and Drug Administration (FDA) had little choice but to raid the place with federal agents, and seize the contaminated heparin before it had a chance to harm or kill any more heparin patients.

And kill, it could have. Ever since contaminated heparin inbound from China began making headlines, it has been reported that nearly 250 deaths have been linked in some fashion to the contaminated heparin, according to a report in the Associated Press. Hundreds more have suffered allergic reactions from heparin manufactured with raw heparin sourced from China. The tainted raw material was found to have been contaminated with a substance that mimics genuine heparin, and escapes detection in rudimentary testing. It was thought that the contamination was deliberate, in an effort to flesh out heparin volumes and cut costs.

China has a growing reputation for exporting manufactured goods containing banned, or harmful substances.

It's not often that the FDA goes to the wall and triggers actual seizures of product, but it does happen and did in this case. What appears to have driven up the FDA's fever meter was their inspection of Cincinnati-based Celsus Laboratories Inc this past April and the discovery of contaminated heparin in two different varieties of heparin products, according to officials. A total of 31 pounds of the contaminated blood thinner was intended for use in diagnostic test kits and medical devices. A further 2 pounds was in the pipeline for use directly with patients.

The FDA returned on November 6th and seized additional products after finding that Celsus' efforts to contact their patients, clients and customers with regard to the contamination problem, were unsatisfactory.

Celsus is reported to be a small manufacturer, as manufacturers go. Nonetheless, the tainted heparin would have wound up somewhere—in someone's veins, and that's one set of veins too many. While the FDA generally prefers to negotiate with manufacturers and other entities when there is a real, or perceived problem with a product, the regulator will resort to calling in the posse if conditions warrant.

While heparin is not completely manufactured in China, the raw ingredient is—sourced from the intestines of pigs. Aside from the contamination, which has so far not been isolated to any one region or any one supplier, raw heparin is often produced in small, hot and unsanitary mom-and-pop heparin sweatshops scattered throughout the various sectors of China. Heparin production, which involves the extraction and cooking of intestines from swine, has evolved to a veritable cottage industry in China, with hundreds if not thousands of families undertaking heparin production in an effort to flesh out the family coffers. Conditions are often deplorable, and such is the breadth of the heparin industry that any attempt to regulate it would remain a significant challenge.

Raw heparin is then imported by American-based manufacturers (and some with actual production plants in China), for finishing and manufacturing into the final product.

The FDA undertook the raid on Celsus after informing the manufacturer that (the FDA) wasn't at all happy with the company's attempts to contact their clients, and therefore maintain some decorum of safety.