The Apotex facilities under US investigation had not been inspected since 2011 and, under this investigation, received failing grades. In February 2013, Apotex received warning letters, but has since failed to address the identified issues. In 2009, US inspectors found that Apotex's manufacturing practices were inadequate and failed to conduct investigations on rejected and contaminated medicines. As a result, FDA imposed a 2-year import ban on Apotex between 2009 and 2011.
Dr. Joel Lexchin, an emergency physician and professor in the School of Health Policy and Management at York University commented that, given the manufacturing problems identified at Apotex, Canadians should be questioning the safety of the drug supply. He also noted that Health Canada should be more proactive when holding companies to account. Dr. Lexchin says that Canada should not require FDA inspection to assess safety of Canadian manufacturing facilities.
U.S. Regulator Warns Canadian Drug Maker Apotex about Quality Control