Warning letter issued in December 2015 have been addressed
Sun Pharma announced that it has received the Establishment Inspection Report (EIR) from the US FDA for the inspection conducted at its Halol facility (Gujarat, India) during the period February 12-23, 2018. The agency concluded that the inspection is now closed and the issues contained in the Warning letter issued in December 2015 have been addressed.
Commenting on the development, Dilip Shanghvi, MD, Sun Pharma says, “This is an important development for Sun Pharma. We remain committed to following the highest levels of quality and 24×7 cGMP compliance at all our manufacturing facilities globally.”
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