Mississauga drug and food testing lab Chemi Pharmaceutical Inc. is hiring extra staff and beefing up its internal audits after Health Canada suspended the company’s licence because of falsified tests.
Chemi’s president Mariana Stavrikov said Wednesday the company has hired a well-known industry consultant from Quality & Compliance Services Inc. for internal audits.
“We are also looking for a quality assurance manager, more auditors and more reviewers after the initial testing,” she told YourMississaugaBiz.com.
On Tuesday, Health Canada announced it had suspended the company’s drug testing licence over falsified tests on 53 products or ingredients. Ottawa also ordered the lab’s customers to stop selling the products temporarily pending a review.
Chemi said the false tests were linked to one of the company’s 24 employees, who has been fired. The company, headquartered near Pearson Airport, has also lost one of its customers, which is looking for another lab to test its drugs.
Since the licence suspension, Stavrikov said the company has done a report on the Health Canada observations and revised procedures and training.
“The system was really in place for 11 years,” she said. “It was working. Now we have to prevent the system from individuals’ intentions, to be stopped right away.”
Stavrikov said the company had three successful audits from Health Canada in the past and the one employee behind the falsified tests was fired Nov. 20.
On Wednesday, Mississauga drug firm Septa Pharmaceutical Inc. issued a statement saying “we do not believe our products to be affected by the issues that are facing Chemi Pharmaceuticals.”
“We have immediately ceased any relationship with Chemi Pharmaceutical and we are in the process of qualifying a new testing laboratory,” said president and CEO Devinder Kumar.
The generic drug maker located on Van Deemter Court said it has also met Health Canada’s request and stopped selling products tested at Chemi while they verify compliance.
However, Stavrikov said Septa was the only client that had moved its business elsewhere when she spoke on Wednesday. The others “have been very supportive,” she said. “And they’re treating this as an isolated case.”
Paul Grootendorst, University of Toronto associate professor of pharmaceutical economics, said the company will have to do some serious work to repair its reputation, including more staff oversight.
“If one person was able to sign off on the inspections, there’s not someone else double checking the results, then the internal controls seem questionable,” he said.
Grootendorst said while Chemi has to overhaul its quality assurance procedures, it could be difficult to stop an employee determined to cause problems. “If they’re serious enough, they could cause havoc in many different situations,” he said. “People are capable of doing a lot of strange things.”
Karen K. Ho 