Dr Reddy's Labs gets 3 USFDA observations for Srikakulam facility
Hyderabad: Dr Reddy's Labs has informed in a BSE filing that the United States Food & Drug Administration (USFDA) has completed a product-specific Pre-Approval Inspection (PAI) with three observations at the Company's formulations manufacturing facility (FTO SEZ PU1) in Srikakulam, 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.
Medical Dialogues team had earlier reported that the Company had received 4 observations from the USFDA after GMP inspection at its API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.
Read also: Dr Reddy's Labs gets 4 USFDA observations for Srikakulam facility
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