Monday, December 22, 2014

Health Canada suspends licence of Ontario chemical testing lab

TORONTO — Health Canada has yanked the licence of a Toronto-area chemical testing laboratory, saying it found falsified results in tests involving a “wide range of products,” including medications and natural food products.
The agency said that in some cases, Chemi Pharmaceutical Inc. did not test finished products or the raw chemicals used to make drugs and other products. Health Canada alleges that bogus results were provided to companies that had contracted the company’s services.

Health Canada, which investigated after receiving a tip alleging spurious practices at the Mississauga, Ont., lab, said Tuesday it is asking companies that used Chemi for quality testing to halt sales of affected products until their safety can be confirmed.
The agency said there is no evidence that the health of Canadians has been compromised.
Reached by phone at her office, Chemi president Mariana Stavrikov said records had indeed been falsified — not by the company, but by an employee that has been fired.
Stavrikov said the man had admitted that he was the one who tipped Health Canada.
Stavrikov would not identify the man, but said he was not a longtime employee. He was one of 24 workers at the firm.
“All the results that had been falsified were done by him ... What this shows is that one sabotager can sabotage the system,” she said. “The products are safe. We’ve committed to retest all (the products).”
Paul Glover, assistant deputy minister of the Health Products and Food Branch, said Chemi was involved in a wide range of testing of products.
“So we have everything from veterinary drugs, to some natural health products to potentially some products used in foods to cosmetics to over-the-counter medicines to prescription products,” Glover said in a media teleconference from Ottawa.
He said Health Canada has so far uncovered 53 products that need to be retested, and is waiting to hear from manufacturers about another 25 products, which may also need to be put through testing again.
“The net result is that any facility that was using this institution for testing to ensure quality of their product will need to rerun the tests to make sure those products are safe.”
A list of products that require further testing is available at Health Canada’s website: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/—2012/2012—184l t-eng.php
Only a portion of Chemi Pharmaceutical’s work involved testing of finished products before they were released on the Canadian market.
“Some of the materials (tested) are raw materials that are used to manufacture finished products, some are the finished product,” said Dr. John Patrick Stewart, acting senior executive director of the Therapeutic Products Directorate, a division of Health Canada.
Stewart said a limited number of prescription drugs are on the list — including some used to manage high blood and diabetes.
“We have no reports or evidence that there is a problem with safety or performance of these drugs,” he said.
Glover said the RCMP has been alerted about the alleged faked testing at the company, which had its licence suspended Monday.
The suspension came after inspectors made a surprise visit to the lab following a phone tip in November alleging that Chemi was falsifying records.
Health Canada inspectors had been at the lab in early October performing the latest of numerous routine examinations the agency has performed since the company was licensed in January 2003.
During prior inspections, Glover said the privately owned company was co-operative during such visits and “had a compliant rating with us.”
“We did see some unusual things in our October inspection that led us to have some very serious concerns that we had documented with them that they needed to correct, subject to a surprise inspection in order to be able to continue to operate,” he said.
That surprise visit was to occur within three to six months. But after receiving the phone tip, a team of inspectors swooped down on the plant and spent two days investigating the allegations.
Once Health Canada has gathered all the information it needs, the “file” will be turned over to the RCMP for further investigation, said Glover, noting that it is a criminal offence under the Food and Drug Act to falsify records or to take actions that could lead to unsafe products for consumers.
A Health Canada official said penalties under the act can carry a fine of up to $5,000 and three years in prison per charge if convicted.
Glover said the monetary value of the services involved is not yet known.
Stavrikov said the company, which she runs with her husband Emil, has not been contacted by the RCMP or any other law enforcement agency.

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