Receives 8 observations under Form 483Alkem Laboratories announced that US FDA had conducted an inspection of the Company's manufacturing facility located at St Louis, USA from 14 January, 2019 to 5 February, 2019 in a phased manner.
At the end of inspection, the Company has received Form 483 that contains eight (8) observations. The Company shall submit to US FDA within the stipulated timeline a detailed response with suitable corrective and preventive measures to address the observations.
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