USFDA issues Form-483 with 3 observations to Alkem Lab's St Louis plant

"There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," the company said.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/STaUbA2
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