If at first you don't succeed....screw up again? That seems to be the pattern atApotex, which was issued yet another warning letter by the FDA for significant violations of the good manufacturing practices for finished pharmaceuticals. The latest warning refers to problems found at the generic drugmaker's Toronto plant, while a June 2009 letter cited a facility in Etobiocoke, Canada.
Basically, Apotex offers a blueprint on how not to make drugs. In its latest missive, the FDA notes there were identical violations at both plants that "demonstrated a lack of adequate process controls and raised serious questions regarding...quality and production systems." Both sites were placed under an import alert last August, by the way, and Apotex recalled 659 batches of different drugs.
The FDA issued the new letter because of "serious and repeat violations from the 2008 and 2009 inspections" and Apotex's last response, which was dated Sept. 3, 2009, "is inadequate and lacks sufficient corrective actions." Subsequent inspections didn't instill confidence. What went wrong? Well, there were contaminated batches. Apotex also returned defective material back into inventory, and re-released failed material that was inadequately reprocessed or retested without a scientifically sound rationale and an assessment of potential impact to product quality.
6 Comments
Apotex probably brought in Chinese technicians to run the plant.
Apotex, the same company that tried to get Dr Nancy Olivieri fired?
See my quick summary here: http://hcrenewal.blogspot.com/2010/02/deja-vu-all-over-again-sheffield.html
See full report here: http://www.caut.ca/uploads/OlivieriInquiryReport.pdf
Ed,
Very impressed at your FDA Warn summary! Would be interesting to know the complete list of recalled APO medicines and info about whether or not some the recalled batches are retroactive recalls.
Also, it seems like there are a lot of issues with various brands of metformin these days. While metformin has gone down in price, you worry that if there is too much price pressure, quality suffers and potential cost savings are lost because of safety issues. Tough to balance quality and cost.
Friends what you're seeing is a clear commitment to profit over quality.
This is very disturbing and disappointing. I take Meformin, and all forms of it, EXCEPT for Apotex's metformin, have a supremely awful smell- kind of like rotting fish. It makes it very difficult to take the medicine. I always prefer Apotex brand because there is no smell at all, making it much easier to take. But now I not only have to worry if some of my health issues were exacerbated by tainted batches, but I am forced to use another generic that smells repulsive. It is extremely alarming to know that a brand I trusted was so negligent and careless about their manufacturing, and worse still, they seem completely indifferent about correcting their violations by being so unresponsive to FDA warnings. Don't they care about their consumers and staying in business? Shame!
What, if anything, has been the role of Health Canada in the Apotex mess?