Details released by the agency last week reveal that, since at least 2006, Ranbaxy employees refrigerated samples that were supposed to be stored at room temperature to test their stability over time. In another instance, the plant reported stability test results for tablets of fluconazole, an antifungal drug, and ciprofloxacin, an antibiotic reserved for severe and life-threatening infections, as occurring at the required time intervals of months; but employees actually conducted all the tests on the same day or within a period of days. One audit of 15 applications approved for the US market found 1,676 errors, including errors in dates of analyses, packaging and stability test results. And during a 2008 inspection, plant records were found to contain the signatures or initials of Ranbaxy employees who were not present in the facility on the dates documented in the batch recordsFor some reason that does not sound surprising to me. There is a mad rush to plunge into the generics market once a lucrative drug patent expires, and companies may not engage in 100% quality control during this frenzy. Clearly, with great power comes great responsibility. Derek also has a post.
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