Canadian hospitals are scrambling to find sufficient quantities of certain generic drugs after the manufacturer recently slowed down production at its three Sandoz North American plants, including one in Boucherville, Quebec. The company is doing so to address issues raised by the U.S. Food and Drug Administration.
Last November the U.S. FDA issued a warning letter to Novartis International stating the Canadian plant failed to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.
In the November 18, 2011 letter, the FDA stated specifically of the Boucherville plant “your failure to implement corrective actions and prevent future recurrence is indicative of an ineffective quality system.”
So where is Health Canada on this? Health Canada also inspected the plant AFTER the U.S. FDA and said they found no issues.