The US Food and Drug Administration (FDA) has cleared Cipla of the four violations it observed during an inspection in November conducted at the company’s Patalganga manufacturing plant in Maharashtra, the company said in a filing with exchanges.
The US regulator issued an establishment inspection report (EIR), which indicates closure of an inspection.
“…following the inspection by the United States Food and Drug Administration (USFDA) at the Patalganga manufacturing facility of the Company from November 4, 2019 to November 13, 2019, the Company has received the Establishment Inspection Report (EIR), indicating closure of the inspection," Cipla said.
An establishment inspection report is given to a manufacturing plant by the US FDA after the regulator is satisfied that there are no violations at the plant and that all violations of good manufacturing practices observed at the plant have been remediated.
During the inspection on 4-13 November, the US FDA inspector had observed four instances of violations of good manufacturing practices.
The Patalganga plant manufactures both active pharmaceutical ingredients, which are key raw materials for medicines, as well as formulations, and these are largely exported to markets like the US.
At 2 pm, shares of Cipla were up 0.1% at ₹480.80 on the National Stock Exchange.