Tuesday, November 13, 2012

FDA finds bugs, bird and contamination at Ameridose plant

Really?!  They said what?!

FDA finds bugs, bird and contamination at Ameridose plant - Vitals:

"Ameridose officials defended the company's practices in a statement:

"While Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product, and have always been guided by Good Manufacturing Practices (GMP) referenced in federal regulations, Ameridose is committed to addressing all observations in order to enhance our existing systems. We are in the process of preparing a full response for presentation to the FDA.”"
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1 comment:

Austin Lee said...

The FDA's Office of Global Regulatory Operations and Policy posted a 20-page summary online, detailing the agency's inspection at Ameridose, the sister company of the Framingham, Massachusetts-based New England Compounding Center, which is linked to meningitis outbreak: http://goo.gl/ACl4m

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