Sunday, April 18, 2010

FDA Issues Second Warning Letter to Apotex

The Food and Drug Administration has posted on their website a March 29th warning letter to Apotex, Canada’s biggest drug company citing lapses that included charred particles in a diabetes drug, contamination of an antihistamine and a drug cross-contamination that resulted from inadequate cleaning of manufacturing equipment.

The FDA letter also claims that Apotex had failed to notify regulators in a timely fashion about such problems.

This is the second warning letter by the FDA to Apotex is less than a year which is highly unusual for the agency.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing concerns by foreign pharmaceutical companies have been discovered within the supply chain that could have been detected at various points of the supply chain by readily available material authentication solutions.

The New York Times has an excellent article about this FDA letter, written by Natasha Singer and published on April 15th.

To view this article, visit:

To learn more about material authentication solutions, visit:

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