Dr Reddy's Srikakulam unit receives Form 483 with 2 observations

Srikakulam unit is among three facilities that received warning letter from US FDA in Nov 2015

Dr Reddy's Laboratories Limited in a disclosure on Tuesday said it has received a Form 483 with 2 observations from the US Food and Drug Administration(US FDA) for its active pharmaceutical ingredients(API) plant at Srikakulam in Andhra Pradesh.

"The audit of our API manufacturing plant at Srikakulam, Andhra Pradesh by the US FDA, has been completed today. We have been issued a Form 483 with 2 observations, which we are addressing," the company said in a disclosure to Bombay Stock Exchange.

Srikakulam unit is among the three manufacturing facilities that had received a warning letter from the US FDA in November 2015.