Since Health Canada announced Tuesday that it had pulled the "establishment licence" for Chemi Pharmaceutical, the company's clients have begun retesting their products internally or at other labs to confirm their safety.
Mariana Stavrikov, president of Chemi Pharmaceutical, said Wednesday that the quality control lab has an 11-year history and a perfect record with Health Canada.
"Our history was transparent, clear and fully compliant with [Good Manufacturing Practice] regulations," Stavrikov said. "Unfortunately, I was subject to a sabotage."
A former employee falsified results, sent cellphone scans to Health Canada and admitted to the regulator what had happened, Stavrikov alleged. He had been fired after fewer than six months on the job, she said.
Paul Glover, assistant deputy minister of the health products and food branch at Health Canada, alleged that in some cases, tests were fabricated or never completed.
The company's website says it tests products and ingredients that could be used in veterinary drugs, natural health products, food, cosmetics and medications.
"Our systems should be strong enough to identify the problem and deal with it," Stavrikov said.
To that end, she said the company has submitted an appeal to Health Canada and is working with a consulting firm to strengthen its quality and compliance services.
Law enforcement officials informed
Originally, Health Canada listed 53 products and ingredients that it said needed to be retested before sales could resume. As the company's clients submit re-testing information to the regulator, that list is being whittled down, which Stavrikov called a very good response.
For example, Health Canada is no longer requesting a halt on sales of Septa Pharmaceutical's generic antibiotic ciprofloxacin. Septa said Tuesday that it was shocked by what transpired and that it is looking for a new testing laboratory for its confirmatory work.
Law enforcement officials, including the RCMP, have been informed about Health Canada's findings.
Chemi Pharmaceutical's 24 employees in Mississauga are still working. They are implementing changes, training and organizing laboratories, Stavrikov said.Suggest a correction