The United States Food and Drug Administration (USFDA) completed its audit of the the company’s formulation manufacturing facility and issued a Form 483 with 13 observations, Dr Reddy’s said in a filing to the stock exchanges.
In an emailed statement, the company said it has no “further comments to offer on this at this point”.
A Form 483 is used by the U.S. FDA to document and communicate concerns discovered during plant inspections.
Dr Reddy’s had received a warning letter from the regulator with regard to this facility in November 2015. After the commitments made by the company as part of its response to the warning letter were completed, a re-audit of the facility was scheduled for the first quarter of 2017, the company said in a presentation made in January 2017.
The company is addressing the observations made by the regulator, the stock exchange filing added.
On February 21, the company’s active pharmaceutical ingredients (API) manufacturing plant at Miryalaguda in Telangana was issued a Form 483 by the U.S. FDA with three observations relating to violation of norms.