IPCA Pithampur unit in minimally acceptable state of compliance by US FDA

Pharma player IPCA Laboratories said that its formulations manufacturing facility at SEZ Indore has received the Establishment Inspection Report from the US Food and Drug Administration (US FDA).

Shares of the company were trading marginally up at Rs 985.75 at 9.55 am on NSE.

The regulator classified the , Pithampur, Madhya Pradesh, unit as voluntary action indicated (VAI). This means that the facility is considered to be in a minimally acceptable state of compliance with regard to current good manufacturing practice (CGMP). The inspection was conducted from June 15 to June 23. At that time, the company had received eight Form 483 observations.

A CNBC-TV18 report had said that labs at the unit did not have scientifically sound and appropriate test procedures and that procedures applicable to the quality control unit were not fully followed.