Responsibility for Quality Lies with Importers - The Heparin Scandal
Paul Midler of The China Game has a blog post titled Heparin Case: China Says Responsibility For Quality Lies With Importing Nations which introduced us to the Heparin scandal. For those not yet in the know, Heparin is at the heart of a scandal where an unlicensed factory in China is reportedly responsible for causing 4 deaths and over 300 allergic reactions.
Heparin is a drug made from hog intestines and is vital when used in the dialysis process. There are two companies making Heparin, ATP and Baxter. Baxter has been outsourcing part of the production to China and it turns out this factory was unlicensed. Watch this video by Today’s Machining World explaining the situation.
The FDA has been tasked with inspecting the factory involved in Changzhou.
Karen Riley said that the agency’s inspection team has completed their inspection of the China facility and a “number of potentially objectionable conditions” were identified relating to the firm’s manufacturing process.
While it’s terrible that people died and that others were injured in this unfortunate incident, there is a lesson to be learned here. As the global economy has grown so fast, it’s clear government agencies have not kept up, neither on the China side nor the US side. While government may play a role, it’s up to the purchaser and importer to ensure safety for the products they develop and sell. Only personal responsibility, sometimes even at an additional cost, will provide people with safe products.
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[…] done - period. Not to go into the much publicized issues of quality or with ingredients as in the Heparin Scandal, we can tell you that if the Chinese are focused on something they want, it will get done and […]
[…] largest and most sophisticated companies in the world face this lesson – review this post on the Heparin scandal for yet another example. If you followed the news on the Heparin sourcing issue, you will find that […]