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.