Health Canada suspended Chemi’s ‘establishment license’ earlier this week, reporting that it discovered evidence the Ottawa-based contract testing laboratory had falsified results during an inspection late last month.
Sean Upton, Health Canada’s senior regulations officer told Outsourcing-pharma.com “The most recent inspection took place on Nov. 22 and 23 at a location in Mississauga, Ontario.
"Test results were falsified or in some instances, no tests were performed and results were made up," He said, adding that “11 companies had products tested at the facility that may require further testing.
Upton went on to say that another 15 companies whose products were analysed at the Chemi lab "have indicated that the compromised testing procedures do not require them to halt sales."
While it has not received evidence of any adverse events related to the improperly tested products, Health Canada has asked the 11 companies involved to temporarily stop selling them until their safety can be confirmed through re-testing.
Upton confirmed this and told us that: “There is no set timeline for the investigation.”
UPDATE: Health Canada told Outsourcing-pharma.com that as of 12/12/2012 only nine products made by four companies need to be retested.
In a development late yesterday, Chemi president Mariana Stavrikov has alleged that her firm is a victim of sabotage and called on Health Canada to reinstate its establishment license.
Stavrikov told Canada’s CBC news that: “Our history was transparent, clear and fully compliant with [Good Manufacturing Practice] regulations,” adding that "unfortunately, I was subject to a sabotage."
She also told the country’s SunNews that a similar story, attributing the actions to an ex-manager who she alleged had been “somewhat aggressive in nature against employees and he had them sign documents supporting his reports.”
She also alleged this employee had falsified test results and then notified Health Canada prompting the visit by Health Canada.