FDA Warns Mylan Facility Over Quality and Data Issues

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.

Frequent invalidation of initial failures without cause led the facility’s laboratory to exclude large amounts of data that would alert the company to problems in the laboratory system, according to FDA. Failure to identify trends in OOS investigations is a repeat observation from a previous FDA inspection in March 2015.

The company also failed to develop a corrective and preventive action plan for errors it pinned on laboratory processes and failed to include all relevant data.

Inspectors also found the facility’s quality control unit to be inadequate. According to FDA, the unit did not monitor and investigate error signals sent by its computer systems indicating loss of GMP data and did not try to determine how much data were lost or what they pertained to until after FDA’s review.

Data loss was frequently blamed on Internet connectivity or power cord disconnection, but the facility offered no explanation for the frequency of these issues and failed to investigate ways to reduce them.

The FDA called on the facility to conduct a full investigation into the scope and extent of any data recording inaccuracies.

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