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The agency cited the company’s India facility for batch failures and data integrity problems.
FDA sent warning letter to Mylan Pharmaceuticals, Inc., dated April 3, 2017, regarding an inspection of the company’s Mylan Laboratories Limited facility in Maharashtra, India conducted from Sept. 5–14, 2016. Current good manufacturing practice violations were found during the inspection that included data integrity issues and failure to investigate batch failures.
According to the agency, the company failed to properly investigate approximately 72% of initial out-of-specification (OOS) assay results to determine root cause. FDA determined the company had failed to implement a CAPA (corrective actions and preventive actions) plan to mitigate errors associated with the company’s laboratory processes. The agency asked the company to provide trend analysis results of all OOS results, including confirmed root causes and the initial OOS results.
Mylan Pharmaceuticals was also cited for data integrity issues including the failure to monitor and investigate error signals generated by chromatography computer systems. “Your quality unit did not comprehensively address the error signals or determine the scope or impact of lost or deleted data until after these problems were reviewed during our inspection,” the agency stated in the warning letter.
Once again, the company failed to perform a CAPA plan. “Although you showed our investigator isolated examples of interrupted, missing, deleted, and lost data for which you had opened investigations, you reached similar conclusions in many of these investigations regarding the root cause of your loss of data integrity but failed to take appropriate corrective action and preventive action in response. Our investigator observed that you attributed numerous incidents to power interruptions, connectivity problems (disconnection of the Ethernet or power cord), and instrument malfunctions. You could not explain why these events occurred with frequency in your laboratory, nor had you undertaken a comprehensive investigation into the problem or sought to correct it and prevent its recurrence,” the letter stated.
FDA is asking the company to provide an investigation into the extent of data inaccuracies, a risk assessment of the potential effects of observed failures on product quality, and a management strategy for a CAPA plan.