FDA notes data falsification at Indian plant

The FDA placed one of Wockhardt's Indian plants on an import alert in May when it found, among other problems, that it was hiding data about test failures from the FDA. And last month German drugmaker Fresenius Kabi fired the managers at an Indian facility for essentially the same thing. However, the data-manipulation trend in India continues.

This time, an FDA warning letter to an Indian drugmaker says a quality-control chemist admitted he "had recorded false visual examination data in the logbooks for reserve samples" at the order of a manager. The observation was made during a March inspection of the Posh Chemicals plant in Hyderabad. The FDA posted the warning letter this week to its website. The agency has asked for a thorough investigation into the extent of the falsification, the role played by the manager and how the API maker intends to prevent future problems.

That was not the only record-keeping concern the FDA found. It also found that there were no restrictions to access lab data tied to testing equipment and no audit trails to follow, raising questions about whether other employees may have altered or deleted test results.

Read more: FDA notes data falsification at Indian plant - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-notes-data-falsification-indian-plant/2013-08-22#ixzz2co4FizFD 
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