Urine, Lies and a Wayward Drugmaker: FDA Tells Off Wockhardt
7/24/2013 7:34:17 AM
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File this under ‘What chutzpah!’ The warning letters issued by the FDA often contain alarming – and, sometimes, amusing - details about infractions. But the July 18 letter sent to Wockhardt, which was recently barred from making medicines for Europe, contains some captivating practices that are certain to invite regulatory scrutiny for quite some time to come. For starters, during an inspection last March, an FDA investigator spotted torn raw data records in the waste area and asked a quality assurance officer to remove the documents for review. So what happens?
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