Action Plan Prepared by Apotex
Apotex Pharmachem is the largest manufacturer, researcher and developer of active pharmaceutical ingredients in Canada. It has in its name multiple patents in the U.S. and Canada.The Brantford facility of the company is the city's third largest manufacturer and employs more than 400 people.
A company spokesman said that issues raised by federal regulators following a tour of the Apotex Pharmachem facility in Brantford do not reflect the safety or effectiveness of the company's products. Elie Betito, the company's director of public and government affairs, said in a statement that "Following a routine internal audit conducted by Apotex and subsequent regulatory inspections by the FDA and Health Canada at our Brantford facility, several areas for improvement was identified," Elie Betito, the company's director of public and government affairs. These observations did not in any way reflect the safety or effectiveness of our products."We are confident that our facilities, systems and procedures meet or surpass industry standards." He also said that assessment of ach issue was done by Apotex and an action plan was prepared.
Concerns were raised by Health Canada and FDA regarding with regards to the computer systems security and the cleaning of equipment used in the manufacture of drugs following inspections conducted in 2014. Therefore, instances were noticed by the inspectors whereby computerized systems didn't have enough controls to prevent unauthorized changes to data, which left open the possibility that test data could be manipulated and altered. But, after subsequently reviewing the data, no evidence of falsification of data was found.
No critical findings were made by Health Canada which showed "validation deficiencies" for processes . A final report is being prepared by Health Canada about its inspection but, before making it public, it will be shared with the officials of Apotex.