Mr. Speaker, Health Canada most recently conducted a good manufacturing practice, GMP, inspection from January 24 to February 10, 2012, of Sandoz Canada’s Boucherville plant, where products for sale in Canada are manufactured. No risk to the health and safety of Canadians using health products manufactured at the Sandoz Boucherville facility for sale in Canada was identified by Health Canada. A report was issued to the company on February 20, 2012, with the observations of deficiencies noted in the plant. Most GMP inspections result in the identification of deficiencies. This alone does not automatically result in a non-compliant rating. The deficiencies reported in the February 20, 2012, report were not considered to be critical, and a ‘compliant’ rating was issued. For more information on GMP, members may visit the following link: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/index-eng.php.
Information was exchanged between Health Canada and the U.S. Food and Drug Administration, FDA, during the November 2011 and March 2012 period. This information included a heads-up notice that Health Canada received on November 8, 201,1 from the FDA, advising of its intention to issue and post a warning letter to Novartis International AG in Switzerland, Sandoz’s parent company, regarding three facilities: the Boucherville, Quebec, site and two facilities in the United States. The FDA’s heads-up also included a copy of the FDA’s deficiencies noted during its August 2011 inspection, FDA form 483. In response to this heads-up, Health Canada Inspectors inspected Sandoz’s Boucherville facility on November 17, 2011. As part of this visit, it was confirmed that the only Boucherville product that was ultimately mentioned in the FDA warning letter was not sold in Canada. As such, no risk to the health and safety of Canadians was identified from this product. Health Canada did not receive an advance copy of the FDA warning letter.
In March 2012, the FDA confirmed that no further action would be required of Sandoz subject to the remediation plan to be taken at Sandoz U.S.A. sites and the action plan following the fire at the Sandoz Quebec site. It should also be noted that the U.S. FDA inspection report concerning the deficiencies noted by the U.S. FDA on November 8, 2011, has yet to be finalized.