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| Apotex's Bangalore facility--Courtesy of Apotex |
In April, the FDA banned a plant in Bangalore, India, owned by Canadian generic drugmaker Apotex. A warning letter sent Monday by the FDA explains why: Among other issues, it found that the company 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.
"According to laboratory analysts interviewed during the inspection, the common practice was to complete the analysis and to record the sample preparation data only if the results were acceptable," the letter reads. "If the results obtained were atypical, a fresh sample was to be prepared and analyzed. The original sample testing was not recorded."
According to the warning letter, Apotex blamed the issue on operators that were not following procedures. When the issue was pointed out, it looked deeper and said it found 9 instances in August 2013 of the same problem. But the FDA wants to know why it didn't dig deeper and find out how extensive this cover-up was. Not only that, but the FDA said retesting products to get passing results was not new at the plant. The same issue had been noted in inspections in 2006 and 2010.
The company has said it is working with the FDA to resolve the issues and the agency acknowledged that Apotex has hired an outside consultant to help it get issues at the plant fixed. But it said it wanted specific problems addressed and laid out 7 steps it wants the drugmaker to take to improve its processes. It also ordered it to find out just how many and which batches of drugs shipped to the U.S. relied on faked or retested data.
This is far from the first time for the generics company to run afoul of FDA expectations for manufacturing standards. 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. But the FDA last year returned to inspect the same plants and again issued warning letters for more problems it said it found there.
The Apotex plant in Bangalore is among a number of Indian plants banned by the FDA this year, and faking analytics was a theme common to all of them. The bans included two Ranbaxy Laboratories plants, two from Wockhardt and one from Sun Pharmaceuticals, which has since struck a deal to buy Ranbaxy.
- here's the warning letter