Inspections American Canadian pharmaceutical companies reveal systemic problems that have jeopardized Canadian patients.
Installing Apotex Bangalore in India was criticized by the Food and Drug Administration of the United States for failing to report the results of unfavorable drug quality testing.
American patients were put at risk by prescription drugs that Canadian pharmaceutical companies sold with the knowledge that their products were defective, Star investigation has found.
Using records obtained through the United States freedom of information laws, the star also found other Canadian companies have:
Hidden altered and in some cases destroyed test data that showed their products were contaminated or potentially unsafe.
No evidence of side effects experienced by consumers take their drugs is reported.
Since 2008, more than 40 Canadian pharmaceutical companies, including Toronto-based Apotex generic giant, have been cited for serious violations of manufacture.
All these violations are detailed in the inspection reports provided to the star not Health Canada, but the Food and Drug Administration (FDA), which also inspects Canadian facilities.
The research found that the star as strict and transparent laws FDA enforces drug manufacturing, Health Canada leaves Canadians in the dark, keeping secret details of its inspectors found problems.
Meanwhile, medicines and ingredients banned drugs in the American market has been allowed by Health Canada at Canadian pharmacies.
The inspection documents obtained by the Star show:
In June, at a facility in Bangalore, India, which makes drugs bound for North America, Apotex employees did not report test results and records adulterated unwanted bacterial growth test.
Generic drug maker Taro Pharmaceuticals of Brampton drugs remained on the market despite evidence showing the company lots of drugs damaged before the expiration date on the label.
Cangene Corp., a drug manufacturer Winnipeg, could not tell the authorities of blood clots, fever and other side effects associated with their products.
The USA FDA inspects facilities in Canada and around the world where the ingredients of drugs and medicines for the American market are made. The regulator can ban drugs the American market or preventing a company introducing new products to the manufacturing and safety problems are fixed.
The FDA reports do not specify all the countries where drugs made by the companies inspected were sent. The star was found that many of these same drugs are also made for Canadian consumers, and factories are inspected Health Canada also.
There have been at least 19 Apotex inspections by the FDA since 2008, 16 of them resulting in conclusions called "objectionable" or noted as "repeated deficiencies." In one case, the FDA said the company could not defend "their legal obligation."
During an interview at a Toronto factory Apotex, and email correspondence, president and CEO Dr. Jeremy Desai and another manager did not question the conclusions of the FDA and told the star that is the signature fixing problems and their products are safe.
Desai told the Star "compliance is a journey" and his company has dealt with what he calls the "procedural lapses" identified by the FDA and has invested in improved data collection programs and staff training.
The Star found details of inspections that the FDA inspection dates and makes the results available to the public on its website. The American regulator has published dozens of online warning letters to Canadian companies, many of which detail the appalling conditions in drug manufacturing facilities.
A 2010 letter to Apotex revealed details of previous inspections of its facilities in Toronto, where American inspectors found the company antihistamine pills and distributed diabetes made with contaminated ingredients. Apotex recalled more than 600 lots of drugs made at its facilities in GTA Canadian and American markets.
In contrast, Health Canada does not tell the public the number of times it has been inspected Apotex individual facilities or other large drug companies.
Installing Apotex Bangalore in India was criticized by the Food and Drug Administration of the United States for failing to report the results of unfavorable drug quality testing.
American patients were put at risk by prescription drugs that Canadian pharmaceutical companies sold with the knowledge that their products were defective, Star investigation has found.
Using records obtained through the United States freedom of information laws, the star also found other Canadian companies have:
Hidden altered and in some cases destroyed test data that showed their products were contaminated or potentially unsafe.
No evidence of side effects experienced by consumers take their drugs is reported.
Since 2008, more than 40 Canadian pharmaceutical companies, including Toronto-based Apotex generic giant, have been cited for serious violations of manufacture.
All these violations are detailed in the inspection reports provided to the star not Health Canada, but the Food and Drug Administration (FDA), which also inspects Canadian facilities.
The research found that the star as strict and transparent laws FDA enforces drug manufacturing, Health Canada leaves Canadians in the dark, keeping secret details of its inspectors found problems.
Meanwhile, medicines and ingredients banned drugs in the American market has been allowed by Health Canada at Canadian pharmacies.
The inspection documents obtained by the Star show:
In June, at a facility in Bangalore, India, which makes drugs bound for North America, Apotex employees did not report test results and records adulterated unwanted bacterial growth test.
Generic drug maker Taro Pharmaceuticals of Brampton drugs remained on the market despite evidence showing the company lots of drugs damaged before the expiration date on the label.
Cangene Corp., a drug manufacturer Winnipeg, could not tell the authorities of blood clots, fever and other side effects associated with their products.
The USA FDA inspects facilities in Canada and around the world where the ingredients of drugs and medicines for the American market are made. The regulator can ban drugs the American market or preventing a company introducing new products to the manufacturing and safety problems are fixed.
The FDA reports do not specify all the countries where drugs made by the companies inspected were sent. The star was found that many of these same drugs are also made for Canadian consumers, and factories are inspected Health Canada also.
There have been at least 19 Apotex inspections by the FDA since 2008, 16 of them resulting in conclusions called "objectionable" or noted as "repeated deficiencies." In one case, the FDA said the company could not defend "their legal obligation."
During an interview at a Toronto factory Apotex, and email correspondence, president and CEO Dr. Jeremy Desai and another manager did not question the conclusions of the FDA and told the star that is the signature fixing problems and their products are safe.
Desai told the Star "compliance is a journey" and his company has dealt with what he calls the "procedural lapses" identified by the FDA and has invested in improved data collection programs and staff training.
The Star found details of inspections that the FDA inspection dates and makes the results available to the public on its website. The American regulator has published dozens of online warning letters to Canadian companies, many of which detail the appalling conditions in drug manufacturing facilities.
A 2010 letter to Apotex revealed details of previous inspections of its facilities in Toronto, where American inspectors found the company antihistamine pills and distributed diabetes made with contaminated ingredients. Apotex recalled more than 600 lots of drugs made at its facilities in GTA Canadian and American markets.
In contrast, Health Canada does not tell the public the number of times it has been inspected Apotex individual facilities or other large drug companies.
