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21 May 2014

FDA Warning Letter Says Sun Pharma Plant Hid Batch Failures

A warning letter for a now banned Sun Pharmaceutical plant in India, posted 20 May 2014 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.


The letter says inspectors found problems with testing and record shenanigans in the plant operations for making active pharmaceutical ingredients and finished drugs. It says when Sun was made to investigate problems, it uncovered 47 instances of apparent "trial injections" and results deleted from systems. It says at least some of the batches for which out-of–specification (OOS) results were first noted ended up being shipped to the US anyway.


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