Dr Reddy’s receives five FDA observations on Srikakulam API plant
The US Food and Drug Administration has issued India’s Dr Reddy’s Laboratories with five observations after a recent inspection at its active pharmaceutical ingredient (API) manufacturing plant at Srikakulam.
“The audit of our API manufacturing plant at Srikakulum, Andhra Pradesh (CTO VI) by the USFDA has been completed on January 28, 2020. We have been issued a Form 483 with five observations,” Dr Reddy’s said in a regulatory filing to the Bombay Stock Exchange. “We will address them comprehensively within the stipulated timeline.”
The company gave no indication of the nature of the observations.
While a Form 483 is not an official warning letter, observations are listed when, in an investigator's judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of the FDA's requirements.
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