Alkem Laboratories today said USFDA has "successfully closed" inspection of the drug firm's manufacturing facility at Daman.
"The USFDA had conducted a bio-analytical inspection at the company's manufacturing facility located at Daman from October 24 to 28. The inspection has been successfully closed without any 483 observations," Alkem Laboratories said in a BSE filing.
An FDA Form 483 is issued to management at the conclusion of an inspection "when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts".
In September this year, Alkem Laboratories said it had received inspection report with 13 observations from the US health regulator after the inspection of its manufacturing facility at Daman.
Shares of Alkem Laboratories were trading 1.66 per cent up at Rs 1,645 on BSE.
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