US FDA criticizes quality systems at Mylan NV's Nashik plant
The US regulator detailed its concerns in a letter published on Tuesday, telling the Netherlands-domiciled drug firm it needs to address problems observed during an inspection conducted last September.
The Food and Drug Administration (FDA) said the site’s quality control unit is inadequate, citing instances of missing analytical data.
It also raised concerns about Mylan’s decision to invalidate out-of-specification (OOS) test results, pointing out that it identified similar practices when it last audited the facility in 2015.
The agency concluded that: “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”
It acknowledged Mylan’s decision to hire a consultant to audit the site and urged the firm to fully investigate the extent of inaccuracies in its data records, assess the potential effects of quality failings and provide a corrective action and preventative action plan.
In an email Mylan told us "We are working closely with FDA to respond to and address the issues raised in the letter as comprehensively and expeditiously as possible."
The firm added: "As FDA standards for our industry continue to evolve, we are dedicated to continually enhancing our systems and processes with a deliberate, thorough approach to assure sustainable quality across our entire network of facilities."
