"The audit of our API manufacturing plant at Srikakulam, Andhra Pradesh by the United States Food and Drug Administration (USFDA), has been completed today," Dr Reddy's Laboratories said in a filing to the BSE.
The company has been issued a Form 483 with two observations, "which we are addressing", it added.
Dr Reddy's Laboratories, however, did not disclose details about the observations.
As per the USFDA, a "FDA Form 483 is issued to firm 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 (FD&C) Act and related Acts".
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