Apotex Slammed With Another Serious Warning Letter
March 20th, 2013 // 3:56 pm @ jmpickett
Tomorrow – The Quality Manager Gets Fired and the $125,000 Compliance SNAFU
In the latest row between the FDA and Apotex over its manufacturing practices, the agency has issued another warning letter that takes the generic drugmaker to task for a host of serious violations at two separate plants in Canada. The missive also notes that agency inspectors encountered repeat infractions and a persistent failure to make the necessary corrections.
There is a sad history here. Four years ago, the FDA issued an import alert for all drugs made at two Canadian plants. Until then, Apotex was one of the biggest generic suppliers to the US market, but subsequently recalled 675 batches of different drugs. Shipments were allowed to resume in 2011 (back story), but last May, Apotex turned around and filed a claim seeking hundreds of millions of damages because the import alert ‘decimated’ its business.
In arguing its case, Apotex maintained the plants affected by the import alert produced about 80 percent of the drugs shipped to the US, and the US market accounted for 60 percent of companywide revenue (back story). But the FDA was clearly not going to wait for the case, which was filed before the International Centre for Settlement of Investment Disputes (see this), to be resolved before conducting a new round of inspections.
And so, inspectors were sent last August and the violations cited in the letter are concerning. For instance, a plant in Toronto failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination in drugs that supposedly are sterile. This “raises concerns about the accurate reporting of results in your records,†the FDA wrote in its February 21 letter.
What else? Apotex also failed to investigate batches that did not meet specifications, a problem that occurred over the previous two years and “actions taken often did not prevent recurrence of the problems,†the letter states. The drugmaker also failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.
Apotex may argue that the FDA is unfairly singling out its operations in light of the legal battle, but the agency has every right to monitor repeat offenders. Granted, avoiding a warning letter is not easy, but Apotex has had sufficient experience and should have known by now how to avoid incurring agency wrath. Instead, the drugmaker seems to have tempted fate. You can read the letter and the more detailed issues found during the inspections.
