Apotex Is Warned Again for Ongoing GMP Issues

Apotex’s Toronto facility has received an FDA warning letter citing several GMP deficiencies for finished products, including the alleged use of contaminated ingredients.

The violations demonstrate a lack of adequate process controls and raise serious questions about the company’s quality and production systems, according to the March 29 letter. The GMP failures cited are identical to those noted in a 2009 warning letter about the company’s Etobiocoke, Canada, site, the FDA says.

The repeated violations raised concerns about adequate production and process controls and quality systems, according to the letter. The earlier problems led to an FDA import alert that is still in effect for both sites.
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