Health Canada Begins Publishing Information Regarding Emerging Issues As part of Health Canada's ongoing commitment to openness and transparency, the Department recently began publishing information regarding emerging issues identified through the drug inspection program. This Inspection Tracker provides a snapshot of the potential health and safety issues Health Canada … [Read more...]
HEALTH CANADA ISSUES SUMMARY REPORT FROM AUDIT OF ID BIOMEDICAL (GSK), SAINTE-FOY, QUEBEC
Health Canada recently issued a summary report of their recent audit of ID Biomedical (GSK). Within this report, they presented summaries of both their 2012 and 2014 Inspections. Enclosed are copies of selected sections of both Inspections as well as my additional comments. “2012 INSPECTION: Health Canada's 2012 regular GMP inspection of the Sainte-Foy facility concentrated … [Read more...]
HEALTH CANADA ANNOUNCES GSK AUDIT OF STE. FOY, QUEBEC SITE
AUDIT RELEASE (7/3/14) FOLLOWS THAT OF FDA’S WARNING LETTER GSK (GlaxoSmithKline) recently received a Health Canada inspection report on July 3, 2014, almost a month (6/12/14) following FDA’s issuance of a Warning Letter for the same facility. While Health Canada did not release specifics of the involved issues, it did indicate some of the findings were similar to those … [Read more...]
