When FDA inspected a Heparin supplier, Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., they thought they were seeing the real plant. It turned out that it was only a show facility. The real plant was a shadow plant located somewhere else. The US-FDA Warning Letter later stated, “The inspection revealed that the facility was not manufacturing, and did not appear to have ever manufactured, Heparin Sodium USP (or heparin sodium) for the U.S. market.”See A New Paradigm to Address the High Cost of Vendor Qualification
This case is similar to Baxter Pharmaceutical’s experience with their Heparin supplier in 2008. The result of that deception was that hundreds of patients suffered life-threatening reactions like severe hypotension, low blood pressure and over 80 people died.
http://www.costa-classified-ads.com/manag/3515/a-new-paradigm-to-address-the-high-cost-of-vendor-qualification/ In this article, Mr. Howe went on to point out that saving a few dollars on Chinese imports, may end up costing your company exponentially more.
He continued:
Any pharmaceutical or medical device plant is a very complex place. Unless you plan to take up residence at the vendor you have no chance to understand the true nature of these operations. And what company in today’s cost-cutting climate has the resources to do that? Keep in mind that an audit costs more than what you pay for your auditors to investigate the vendor. The vendor has to spend their time escorting the auditors around, digging out records, and following up on action items. Guess who has to cover that cost. The assumption today is that a BETTER audit means a LONGER audit. There has to be another way.
What’s needed is a new paradigm for vendor qualification; a tool that can drill deeply into the vendor’s operation at low cost; something that can provide a more lasting measure of the vendor’s performance than simply an audit.
Isn’t there a simpler solution? Manufacture drugs in the United States where the company whose name is on the product, can control what goes in them?
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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