Finally, DRL’s Srikakulam API plant gets USFDA nod
New Delhi : Drug firm Dr Reddy's Laboratories said the US health regulator has completed inspection of its Srikakulam facility without making any observations.
"The audit of our active pharmaceutical ingredient (API) Srikakulam Plant (SEZ), Andhra Pradesh, by the United States Food and Drug Administration (USFDA), has been completed with no observations, Dr Reddys Laboratories said in a filing to BSE.
The regulator issues Form 483 observations to a firms management at the conclusion of an inspection to notify it of objectionable conditions at the facility.
As per USFDA, it is issued when 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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