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Two weeks ago, Dr. Reddy’s Laboratories released a very brief statement that the Food and Drug Administration had found some problems with a key plant where the drug maker hopes to produce several generic cancer medications. At the time, though, there were no details, but now the inspection report is available and the infractions do not appear to bode well for the company.

During their visit last month to the facility in Visakhapatnam, India, FDA inspectors found what are called multiple repeat observations of various problems, which is regulatory parlance for manufacturing gaffes that were noted during previous inspections. In fact, half of the quality control problems that were seen had been spotted when FDA staff visited more than a year earlier.

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  • Maybe the FDA should let patients report minor illnesses while taking drugs from factories that have had warnings. That way inspectors might be able to directly track patient reported infections (UTI, fungal, rash) to the shoddy conditions they observed and put careless owners out of biz.

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