The effectiveness of FDA inspection has been over stated. FDA can only assure a good manufacturing practice, but cannot catch a thief pouring toxic brew into the product in a fraction of a second. This is more of a job for FBI or police department. FDA deserve more money, but not for this reason. It is less expensive to just test the crude products before entering the United States.
Crude heparin extract is a by-product of making shells for sausage from pig small intestine. Therefore, it is a byproduct of a food manufacturing process. Everyting is hadled as a food processing and the places are filthy. Baxter knew it from the very beginning. The final steps of purification of heparin performed in the US is a very effective ion exchange process. Because it is so powerful that Baxter neglected the initial manufacturing processes. Intentional criminal addition of superfulfated chondroitin sulfate was entirely unexpected by anyone. In China, everything is possible and all products should be tested before accepted. The test costs 17 cents per dose dispensed to the patient. I believe all heparin crude extract imported to the United States should be tested.
Baxter’s Heparin Problems May Have Connection to China Supplier [View article]
Each Chinese facility should be inspected at least once a year because they are notoriously unreliable. The cost of inspection should be born by Chinese pharmaceutical companies. US taxpayer pay for only those fascilities in the US for a very simple reason: it create jobs here.
Baxter, China and Toxic Heparin [View article]
Baxter, China and Toxic Heparin [View article]
Baxter’s Heparin Problems May Have Connection to China Supplier [View article]