USFDA issues 2 observations for Dr Reddy's Labs Srikakulam facility
New Delhi: Drugmaker, Dr Reddy's Laboratories, has recently announced that the United States Food & Drug Administration (USFDA) has issued a Form 483 with two observations after a PreApproval Inspection (PAI) at its manufacturing facility located at Srikakulam in Andhra Pradesh.
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 judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"This is to inform you that the United States Food & Drug Administration (USFDA) today completed a PreApproval Inspection (PAI) at our formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh," the company stated in the BSE filing.
The inspection was conducted from 30th June, 2022 to 7th July, 2022.
"We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," the company further stated.
Read also: Dr Reddys acquires injectable product portfolio from Eton Pharma for Rs 391 crore
Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, Telangana, India. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.
Dr. Reddy's operates in markets across the globe. The company's major markets include - USA, India, Russia & CIS countries, and Europe.
Read also: Dr Reddy's Labs unit inks drug discovery, development pact with EQRx
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