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Quality Concerns Lead to Suspension of all Products Manufactured by Canadian Company

Posted 11 February 2013 | By Alexander Gaffney, RAC

Canadian regulators have announced the suspension of all medical device licenses issued to or otherwise associated with one medical device manufacturer after being made aware of "concerns about the company's management systems and distribution practices."

That company, British Columbia-based IND Diagnostic, manufactures a wide variety of diagnostic products, including ones to detect pregnancy, infectious diseases, the presence of recreational drugs and other potential health problems.

The company's products-75 in all-were sold by at least 13 private label manufacturers, who purchased IND's products and sold them under their own proprietary brand names.

Regulators did not elaborate on the alleged management system deficiencies. The country uses the ISO 13485 quality system as the required standard for medical device manufacturers, and deficiencies could include risk management practices, sterile manufacturing, establishment of regulatory responsibility, environmental controls, and corrective and preventive action (CAPA) measures.

As of the time of posting, IND Diagnostics had taken down its website, but a cached version of the website from 27 January 2013 says the company has "established an international reputation for excellence in the manufacturing of quality medical diagnostic test kits." The company also said it has products approved or cleared for marketing by the US Food and Drug Administration (FDA), in the European Union under CE marking and in Health Canada. "Our corporate offices and manufacturing facilities are located in an ISO 13485 approved facility in British Columbia, Canada," it said.

Regulatory Focus has reached out to FDA for comment on whether they are investigating the same concerns and will update this space when or if we hear back. In 2003, the company was the recipient of an FDA warning letter that highlighted, among other faults, the company's deficiencies related to quality manufacturing.

Health Canada also said it had been made aware that IND Diagnostics was "importing unlicensed medical devices mainly for export to other countries." The company has since recalled those devices and stopped their import, regulators said.

"Health Canada is continuing to monitor this situation," the agency wrote. "If the Department is made aware of ongoing sales of products whose licenses have been suspended, it will consider taking further action as warranted."

Patients were advised to use authorized alternate diagnostic tools if they felt the need to confirm previous test results, though regulators stopped short of recommending that consumers should do so in all cases and regardless of personal preference.

Tags: ISO 13485

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