Nine Observations given to Dr Reddy’s Laboratory at Srikakulam Plant by USFDA
US FDA recently visited Dr Reddy’s Laboratories manufacturing facility at Srikakulam district which is the bulk manufacturer of active pharmaceutical ingredients and bulk drugs. The US FDA regulators have given nine inspectional observations through form 483 at unit VI of Dr Reddy’s Laboratories’ Srikakulam plant. This unit has been set up in 1990 with a reaction volume capacity of over 570 KL and is an ISO 9001 certified facility.
The observations given by the regulators were related to the procedures and other compliance of the plant systems. These observations have no impact on any activity at the plant and therefore production has not been stopped and continuing in its normal course. One of the Dr Reddy’s Company Official said that it cannot give any statement regarding the number of 483s, the company has received in the last 203 years however the recent FDA audit has no effect on the production activity of the plant.
The company responded in an email stating that it will respond to the observations with their possible solutions within the specified timeframe and start implementing the practices at their plant immediately.