NEW DELHI, Dec 23: Drug firm Alkem Laboratories has received establishment inspection report (EIR) for its Daman facility after it had submitted detailed remedial plan to the US health regulator.
“United States Food and Drug Administration (USFDA) has issued an EIR for its Daman formulation facility which was inspected in September 2016. The inspection has now been closed by the USFDA”, Alkem Laboratories said in a filing to BSE.
USFDA had inspected the facility from September 20 to 29, 2016 and had issued Form 483 with 13 observations, it added.
“Post this, the company had submitted a detailed corrective and preventive action (CAPA) plan to regulator within the stipulated timelines”, Alkem Laboratories said.
“The USFDA has reviewd the CAPA and has found them acceptable,” it added.
(PTI)
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