Regulatory Focus™ > News Articles > Regulators Say Contract Analytical Company 'Falsified' Testing

Regulators Say Contract Analytical Company 'Falsified' Testing

Posted 05 December 2012 | By Alexander Gaffney, RAC

Canadian regulators are scrambling to re-evaluate more than 20 companies' approved and pending products after finding "falsified" testing results during the course of an inspection at Ontario-based Chemi Pharmaceutical, regulators announced on 4 December 2012.

In a statement, Health Canada said it is in the process of "verifying the nature and use of testing done by Chemi Pharmaceutical with the company's customers."

"Our survey of clients to date indicated that only a portion of the company's work involved testing of final products before they entered the Canadian market," it added. "However, as a precautionary step, companies that have had testing done by Chemi Pharmaceutical are being asked to temporarily halt sales of those products until their safety can be confirmed."

At least 11 companies with already-approved products are being asked to halt sales of their respective products, while a further 11 companies had applications for approval pending at the agency which will now undergo further review.

Most affected by the news appears to be Bimeda's Animal Health group, which has at least 18 products affected by the Health Canada request. Other affected companies with marketed products include Germiphere Corporation, Pharmalab, Septa Pharmaceuticals, Trillium Health Care Products and Alpharma Canada.

Officials, though, cautioned that the listing of products was not yet finalized, as regulators scrambled to identify the full scope of Chemi Pharmaceutical's testing services. Officials also said they had "not seen any indication that the health of Canadians has been compromised."

"Health Canada will be working around the clock to confirm the safety of these products, and will take immediate action when required and inform Canadians," it concluded.

The company's website touts its good manufacturing analytical contract laboratory, "specializing in pharmaceutical and natural health products analysis." Also according to its website, the company was last registered by US Food and Drug Administration (FDA) officials in May 2011, leaving open the possibility that US products could also have been put at risk. An analysis of that inspection found FDA determined the facility was adequate, and gave it a "no action indicated" (NAI) notation.

Attempts to contact the company for comment were unsuccessful.

UPDATE: The President of Chemi Pharma, Mariana Stravrikov, has alleged that an ex-manager employee of the company was singularly responsible for an act of "sabotoge" against her company. Stravrikov has called on Health Canada to reinstate Chemi's license to operate.


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