Alkem Labs closes USFDA inspection of Baddi, Daman facility with 2 observations

New Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received 2 observations from the US health regulator for its manufacturing facility located at Daman, India after the closure of the inspection conducted by the regulator.

The facility was inspected from August 26, 2019, to August 30 2019.

"In furtherance to the intimation captioned "US FDA Inspection at Alkem' s manufacturing facility located at Daman, India" dated 30th August 2019, this is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at Daman, India which was inspected from 26th August 2019 to 30th August 2019," Alkem said in a BSE filing.

"In response to the Form 483 issued by the US FDA containing two observations, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines," the company added.

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Alkem Labs further apprised that with respect to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at Baddi, India" dated 23rd August 2019, for the inspection conducted at the Company's manufacturing facility located at Baddi, India from 19th August 2019 to 21 August, 2019 where no Form 483 was received, an Establishment Inspection Report (EIR) has been received for the said facility located at Baddi, India and the inspection has now been closed by the US FDA.

Established in 1973, Alkem Laboratories has a portfolio of over 700 brands covering all major therapeutic segments. It has 16 manufacturing facilities, 14 being in India and two in the United States.

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