USFDA slams Form 483 to ALKEM LAB’s Daman plant, clears Baddi (HP) facility

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Exchanges, Mumbai headquartered pharma company Alkem Laboratories Ltd said of its Baddi (Himachal Pradesh) and Daman plants having inspected by USFDA (US Food and Drugs Administration) in month of August 2019, the regulators have given Establishment Inspection Report (EIR) to the inspected facilities and the slammed Form 483 with two observations to the company’s Daman facility.

In a press-release submitted to the Indian Exchanges by the company titled – “Closure of US FDA Inspection at Alkem’s manufacturing facility located at Daman, India and Baddi, India,” it further read that In furtherance to the intimation captioned “USFDA 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.

In response to the Form 483 issued by the USFDA containing two observations, the Company had submitted a detailed corrective and preventive action (CAP A) plan to the regulator within the stipulated timelines.

The inspection has now been closed by the USFDA.

Further with respect to the intimation captioned “USFDA 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 21st 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 USFDA.


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