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The US health regulator has issued an Establishment Inspection Report (EIR) to Shilpa Medicare for its manufacturing facilities located at Raichur in Karnataka.
Shilpa Medicare has said in a BSE filing that “The USFDA has issued an EIR for the company’s Active Pharmaceutical Ingredient (API) manufacturing facilities located at Raichur, Karnataka which was inspected between December 12-16, 2016. The inspection has now been closed by the USFDA.”
It added that “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 inspection. The USFDA has reviewed the CAPA and has found them acceptable.”
