Abstract
When visiting drug plants outside their home country, U.S. Food & Drug Administration inspectors typically have just a few days to determine whether the facilities comply with manufacturing standards. In the case of Pan Drugs, inspected in July 2014, it was an easy task. “ Our investigator observed holes in the walls and roof which allowed pigeons access near production equipment in multiple manufacturing areas,” read the warning letter that FDA sent to the firm last September to explain why products made at the plant, in Vadodara, India, would be banned from the U.S. Dr. Reddy’s Laboratories, one of the biggest names in India’s drug industry, similarly failed spectacularly. Several days into a late-2014 inspection, FDA officials discovered a lab, not previously disclosed by the firm, that had analyzed active pharmaceutical ingredients exported to the U.S. Inspectors found that the secret lab kept retesting batches that had failed quality tests
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