FDA raises issues with another Apotex plant

Apotex's Brantford, Ontario, plant--Courtesy of Google Maps

Apotex, a major supplier of generic drugs to the U.S., but one that has faced ongoing quality issues with the FDA, has another plant that has come up short during an inspection. This one is in Canada.

The plant in Brantford, Ontario, was cited in a November inspection for equipment that was not properly cleaned and was found to be contaminated, according to a report in The Star. The plant was also cited for not having password-protected computers that could prevent employees from altering or deleting testing data.

Apotex spokesman Elie Betito told the newspaper that the company has responded to the FDA findings "and as such cannot make any further comments."

The FDA last year banned products from an Apotex plant in Bangalore, India, after inspectors found that employees had deleted data of failed test results and then reported that the batches had passed, a practice the FDA said Apotex had received warnings about during inspections dating back 8 years. The agency issued a warning letter to the facility, which has since recalled some of the products produced at the plant.

Apotex has a long history of quality problems uncovered by the FDA. Apotex had products from plants in Toronto and Quebec banned from 2009 to 2011. The ban was lifted in 2011 and Apotex filed suit through the North American Free Trade Act, alleging the FDA action was unwarranted and decimated its business, costing it $500 million in lost sales and expenses. The international authorities sided with the FDA. On a return inspection to the plants in 2013, the FDA found more issues and again issued warning letters.

- here's the Star story

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