India's Marck gets FDA Warning Letter

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The FDA has issued yet another warning letter to a drug manufacturer in India.

Regulatory Focus reports that inspectors of Marck Biosciences found an array of problems during an October-November 2013 inspection, including mold near a sterile area that was so bad “the room had ‘partially caved in.'”

This is in addition to finding dead insects and dead frogs. Inspectors found paperwork equally poor, uncovering what amounted to two sets of books, resulting in mismatches such as official reports indicating that 18 units of a drug batch failed to hit quality control marks, while unofficial records—kept on scrap paper—indicated it was really more like 200 units. Employees also told inspectors they had falsified reports.

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