The FDA has kept a close eye on Chinese heparin makers ever since tainted crude heparin from China was tied to the deaths of dozens of dialysis patients in the U.S. The agency has now 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 warning letter posted by the FDA this week explains why the FDA put Beijing Shunxin Meihua Bio-technical on its import alert list in July. Shunxin manufactures crude heparin for purification into finished API for the blood thinner. But the FDA says the company appears to be getting some of its raw materials from a supplier who is on an FDA watch list of suspect companies that don't carefully monitor the source of their materials.
The warning letter said, "during the review of a list of your suppliers, one of the few documents you did provide, we noted that you are supplied by (redacted), which research indicates has the same physical address as, and is thus an alias of, the (redacted) a firm that is currently on FDA Import Alert 55-03 ... Consequently, your use of this supplier on Import Alert 55-03 led to the appearance of adulteration of your heparin drugs."
In fact, the FDA said test results confirmed the presence of ruminant DNA in one of two samples of porcine crude heparin produced by Shunxin and obtained from one of its Chinese customers. FDA rules require heparin be manufactured only from pig intestines because when "ruminant" animals like cattle are used, there is a chance the raw material could be contaminated with bovine spongiform encephalopathy (BSE).
FDA inspectors didn't get a chance to find out the extent of potential problems because the company "repeatedly" refused to let inspectors into the production area or to review records. The FDA said products from Shunxin will be barred from the U.S. until the FDA can inspect its plant and its records and determine if its manufacturing meets FDA standards.
The FDA now has a list of 34 Chinese companies that it will not allow to sell heparin in the U.S. because of questions about the source of their products and their ability to keep tainted heparin from them. It says many of these use oversulfated chondroitin sulfate (OSCS), a cheap filler product that saves them money, but which can be deadly to patients.
In 2008, contaminated heparin marketed by Baxter International ($BAX) was tied to the deaths of 80 patients. The FDA found the heparin was tainted with OSCS in crude heparin that came from Chinese suppliers. The episode is resulting in a sea change at the FDA, where the FDA assumed the responsibility of inspecting all of the companies that sell FDA-approved products in the U.S.
- here's the warning letter