Wednesday, May 21, 2014
FDA warning letter says Sun Pharma plant hid batch failures - FiercePharma Manufacturing
FDA warning letter says Sun Pharma plant hid batch failures - FiercePharma Manufacturing:
"A warning letter for a now banned Sun Pharmaceutical plant in India, posted today by the FDA, shows employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn't hit. In fact, FDA inspectors fished torn and partially destroyed raw data cGMP records out of the trash."
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