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...]
FDA Warning Letters – Their Relationship to Drug Shortages — An Interesting Counterpoint
Recently (June 12, 2014) I authored a Blog re: “FDA Warning Letters – Their Relationship to Drug Shortages”. This Blog elicited several very interesting comments. Within this Blog, I noted that Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this topic and illustrated the … [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...]
ID BIOMEDICAL CORP RECEIVES WARNING LETTER (6/12/14)
COMPANY CONTINUED TO FIND GRAM NEGATIVES IN PW WATER SYSTEM ID Biomedical Corp, a subsidiary of GSK Biologicals, located in Quebec, Canada was audited by the FDA from March 31 through April 9, 2014. The FDA Investigators documented deviations from CGMP in the manufacture of their biological drug product, Flulaval and its intermediates. Significant objectionable conditions … [Read more...]
FDA Warning Letters – Their Relationship to Drug Shortages
The FDA has become keenly aware within the past several years of the impact that their audits have on the availability of drugs becoming available to the consuming public. Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this and illustrated the “FDA Response to Drug … [Read more...]
