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Issues two observations under Form 483
Alkem Laboratories announced that US FDA had conducted an inspection of the Company’s manufacturing facility located at St. Louis, USA from 14 June 2021 to 18 June 2021.
At the end of the inspection, the Company has received Form 483 with two (2) observations. The Company shall submit to US FDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.
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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)
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First Published: Sat, June 19 2021. 13:03 IST
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