FDA Warns Mylan Facility Over Quality and Data Issues

April 19, 2017

The FDA cited a Mylan Pharmaceuticals facility for massive quality control problems and inadequate data integrity.

The agency issued a warning letter following a September 2016 inspection of a Mylan finished pharmaceuticals facility in Nashik, India, which manufactures antiretroviral drugs that treat HIV, among other products.

Inspectors found that during the first half of 2016, the facility invalidated about 72 percent of initial out-of-specification assay results without thoroughly investigating what caused the initial problem.

For example, one failing test result was simply discarded without investigation, followed by re-testing, with the results of the re-test reported. The facility took no precautions to reduce the “analytical bias” to which it attributed the initial failure.

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