Apotex plant in India hit with third warning letter in 4 years

Apotex, Canada's largest drugmaker, has again had a plant in India cited by the FDA. (FDA)

When the FDA issued warning letters in 2014 and 2015 to the Apotex Research Private plant, it was in part because of testing methods that left doubt about the quality of products coming out of the manufacturing facility in Bangalore, India. Fast-forward three years, and the FDA found that not much has changed.

The FDA this month issued the plant a warning letter, citing it for many of the same issues uncovered in 2014 and 2015. In fact, the agency pointed out that it has found many of the same issues in a number of Apotex plants over the last five years, displaying its frustration that Apotex seems unable, or unwilling, to learn from past mistakes.

“FDA has previously communicated about the need for appropriate and global quality oversight to Apotex senior management during several regulatory meetings,” the most recent letter says. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.”


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“Your quality system has not implemented effective corrective actions to ensure the accuracy and integrity of the data generated at your facility, which is necessary to ensure the safety, effectiveness and quality of the drug products you manufacture.”

RELATED: FDA warning letter scorches a second Apotex plant in India

The agency recommended that Apotex hire an outside consultant that can help it meet cGMP standards at the India plant and others.

Apotex, Canada’s largest pharmaceutical maker, has a long history with the FDA. Two of its Canadian plants were banned from shipping products to the U.S. from 2009 to 2011. New warning letters were issued to the plants in 2013, when the FDA again found issues. Those warning letters were closed out, but soon after, the issues at the India plant came up again.

RELATED: FDA approves first generic under new pathway designed to fight drug price gouging

The warning letter rebukes come even as Apotex last week was selected for an FDA honor. It was awarded approval of the first generic drug under the agency’s Competitive Generic Therapy program, which is designed to streamline approval for generics in drug classes with little or no competition. The Apotex drug was a generic of potassium chloride oral solution to treat hypokalemia.


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