"United States Food and Drug Administration (USFDA) had conducted an inspection at the company's bioequivalence facility located at Taloja from July 10, 2017, to July 14, 2017", Alkem Laboratories said in a filing to BSE.
At the end of the inspection, no Form 483 was issued, it added.
A Form 483 is issued to a company after the inspection when the USFDA investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.
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