Alkem Labs gets 4 USFDA observations for St Louis facility
New Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received four observations from the US health regulator for its manufacturing facility situated at St. Louis, Fen ton Park, USA
The United States Food and Drug Administration (USFDA) inspection was conducted for the facility from 16th August 2019 to 22nd August 2019. Apart from the US facility, the Baddi facility too was inspected from 19th August 2019 to 23rd August 2019. However, it received no observations from the USFDA.
"This is to inform you that US FDA had conducted inspections at the Company's manufacturing facilities located at St. Louis, Fen ton Park, the USA from 16th August 2019 to 22nd August 2019 and Baddi, India from 19th August 2019 to 23rd August 2019," Alkem said in a filing.
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At the end of the inspection, the company received a Form 483 with four (4) observations for the facility located at St. Louis, Fenton Park, USA and no Form 483 is received for the facility located at Baddi, India.
Commenting on the observations, Alkem Labs stated, "The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations for the facility located at St. Louis, Fenton Park, USA and the same is proposed to be filed within the timeline stipulated by 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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