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Shilpa Medicare has said the US health regulator has issued an Establishment Inspection Report (EIR) for its manufacturing facilities located at Raichur in Karnataka.
“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,” Shilpa Medicare said in a BSE filing today.
USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
It further said: “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.“
Form 483 is issued when an investigator observes any possible violation of the laid-down rules.
Shares of the company were trading 5.60 per cent higher at Rs 720.65 on the BSE.
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