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 Observations noted by the FDA. As you may recall from the previous Blog on this subject, FDA Investigators found Gram negative bacteria in the Purified Water systems and an on-going issue with Out of Trend (OOT) results for endotoxin. Health Canada is currently writing a summary report which will be issued upon completion.
Health Canada gave GSK a “Compliant” rating which indicates that the problems do not pose an immediate risk to the citizens of Canada. Even with a “Compliant” rating, corrective actions were required.
The FDA noted that 21% of the plant’s production in 2014 could not be released to market because of GSK’s various problems. The Ste. Foy facility is contracted to produce 53% or 6.36 million of the roughly 12 million seasonal flu vaccine doses that Canada has ordered for 2014-15. Another 23 million does is anticipated for delivery to the U.S.
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