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Drug major Dr Reddy’s on Saturday said it has received four observations from the US health regulator USFDA for its facility at Srikakulam in Andhra Pradesh.
The audit of the company’s API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the Hyderabad-based pharma major said in a regulatory filing. Dr Reddy’s further said that it would address the four concerns within the stipulated timeline.
“The audit of our API Srikakulam Plant (SEZ), Andhra Pradesh, by the USFDA, has been completed on October 25, 2019. We have been issued a Form 483 with four observations,” said Dr Reddy’s. It further said: “We will address them comprehensively within the stipulated timeline.”
As per the US health regulator, “an 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.”
The FDA Form 483 notifies the company’s management of objectionable conditions.
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