New Delhi: Shilpa Medicare on Saturday said the USFDA has issued an Establishment Inspection Report (EIR) for its Jadcherla facility in Telangana.
The US health regulator has issued an EIR for the company’s generic pharmaceutical manufacturing facility at Jadcherla, which was inspected between July 24-28, 2017, Shilpa Medicare said in a filing to BSE.
The inspection has now been closed by the USFDA, it added.
“The company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of the inspection,” it said.
The USFDA has reviewed the CAPA and found it acceptable, it added.