USFDA has given 483 to API Plant of Dr Reddy’s Ltd situated in Srikakulam
Dr Reddy’s Laboratories have got nine inspectional observations in a recent inspection by the US FDA at the API manufacturing facility in Srikakulam district, Andhra Pradesh. These are called 483 observations. The observations are related to the deviations noticed in the standard manufacturing practices.The observations are related to the procedural and other compliances of the plant systems. According to Dr Reddy’s, they will respond to the agency within the required timelines with their remedial plans and start implementing the necessary measures immediately.
According to the company production will continue in the normal way and activity at the plant will not be affected.