Dr Reddy’s Srikakulam Plant Clears U.S. Drug Regulator’s Audit
The U.S. FDA made no observations on Dr Reddy’s formulation facility in Srikakulum.
The United States Food and Drug Administration completed an audit of one of Dr. Reddy’s Laboratories Ltd.’s formulation facility with zero observations, the drugmaker said.
The U.S. FDA completed an audit of the Formulations Plant (SEZ) Unit II in Srikakulum, Andhra Pradesh, a stock exchange filing said.
This is the third facility of Dr. Reddy’s in Srikakulum which has been scrutinised by the drug regulator. In April, its active pharmaceutical facility in Srikakulum was audited without any observations. Earlier in the same month, its active pharmaceutical ingredients manufacturing plant in the same region had received a Form 483 with two observations.
The FDA issues a Form 483 if its investigators spot any conditions that in their judgment may constitute a violation of the U.S. Food Drug and Cosmetic Act and related acts, according to information on the regulator’s website.