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Alkem Labs receives EIR from USFDA for Daman plant

Alkem Labs receives EIR from USFDA for Daman plant

Mumbai, July 24 (UNI) Pharma Major, Alkem Laboratories has received establishment inspection report (EIR) for its facility located at Amaliya, Daman, after it had submitted detailed remedial plan to USFDA.

USFDA had inspected the facility from March 19 to 27, 2018, company said in filing with BSE.

In response to the Form 483 issued by the USFDA containing thirteen observations the company had submitted a detailed corrective and preventive action (CAPA) plan to regulator within the stipulated timelines'.

The inspection has now been closed by the USFDA, filing added

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