Compliance Management

FDA Slaps Dr Reddy's with Form 483

Apr 05, 2017

livemint

Dr Reddy’s Laboratories says it is addressing two observations issued by the U.S. FDA after the agency inspected the drugmaker's active pharmaceutical ingredients (API) plant at Srikakulam, according to an article in livemint. The company did not disclose specific details, however.

“The audit of our API manufacturing plant at Srikakulam, Andhra Pradesh, by the United States Food and Drug Administration, has been completed on Tuesday,” Dr Reddy’s Labs said in a filing to the BSE.

Last month, the FDA completed an inspection of Dr Reddy’s formulation manufacturing facility at Duwada, Visakhapatnam and issued Form 483 with 13 observations.

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