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A warning letter has been issued by the US health regulator to Mylan for violations of good manufacturing norms, including data integrity lapses and failure of quality control at its Nashik facility.
The letter, that has been issued by the United States Food and Drug Administration (USFDA) to the Mylan Pharmaceuticals Inc President Rajiv Malik states that it had inspected the Nashik facility of the company from September 5 to 14, 2016.
It added that there were “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals”, at the facility.
The letter said 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.”
