The Novartis plant in Lincoln, Nebraska is not their only facility under scrutiny. Sandoz Canada Ltd., located in Boucherville, Quebec is under investigation as well; this company is a division of Novartis. Sandoz Canada Ltd. manufactures a wide variety of generic brand drugs. The FDA does not have direct control over a facility located outside the United States; but those companies are subject to FDA inspections. These inspections address good manufacturing practices. The FDA found several violations of manufacturing rules at this facility. One violation is in regards to prevention of microbiological contamination. This plant was supposedly shut down in November 2011.
The company appears to be using the same tactics with this, as with their facility in the United States; no definitive date when the issues will be resolved. The question I pose is this, what happened to quality control? There used to be a sense of pride in products produced by a company, now it is all about a company's bottom line, money.
(conclusion tomorrow from Brandykegs)
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