FDA Warns Canadian Drug Company Of Manufacturing Practice Violations

The Food and Drug Administration told Jubilant HollisterStier General Partnership that it found significant violations of current good manufacturing practice (cGMP) regulations at the pharmaceutical manufacturing facility in Quebec, Canada, according to a warning letter posted March 5 on FDA’s website.

FDA said it found the violations during an inspection that ended March 26, 2012. The agency said it has conducted a detailed review of the company’s response but the response lacks sufficient corrective actions.

Specific violations observed during the inspection include, but are not limited to:

• the company did not thoroughly investigate any unexplained discrepancy or failure of a ...