Dr Reddy’s gets 2 USFDA observations for Srikakulam plant
Dr Reddy’s in a filing to BSE said it is addressing the observations raised by USFDA after the audit of its API manufacturing plant at Srikakulam,
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New Delhi: Drug firm Dr Reddy’s Laboratories on Tuesday said the US health regulator has issued two observations after inspection of its manufacturing plant at Srikakulam.
“The audit of our API manufacturing plant at Srikakulam, Andhra Pradesh by the United States Food and Drug Administration (USFDA), has been completed on Tuesday,” 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”. It notifies the company’s management of objectionable conditions.