Moneycontrol
Jan 10, 2018 03:54 PM IST | Source: Moneycontrol.com

Alkem Laboratories gets EIR for Baddi facility

This is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at Baddi, India which was inspected from 11th September, 2017 to 15th September, 2017.

 
 
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In furtherance to the intimation captioned "Update on US FDA Inspection at Alkem's Baddi Facility" dated 18th September, 2017, this is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at Baddi, India which was inspected from 11th September, 2017 to 15th September, 2017.

In response to the two Form 483 observations issued by the US FDA, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA.

Kindly take the same on record.
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