Drug-maker Dr Reddy’s Laboratories is firming up its response to ‘compliance and procedures related issues’ raised by the US Food and Drug Administration (USFDA) regarding its manufacturing facility in Srikakulam district of Andhra Pradesh.
Remedial plans“We have received nine inspectional observations from the US FDA after their visit to our API (active pharmaceutical ingredient) plant in Srikakulam,” the Hyderabad-based company said in statement.
“We will respond to the agency within stipulated timelines with our remedial plans and start implementing the necessary measures immediately.” Claiming that production continues in the normal course and there is no implication of the observations on any activity at the plant, a Dr Reddy’s spokesperson said these observations largely related to procedural and other compliances of the plant systems.
The USFDA had conducted an inspection audit of the plant a week ago.
The company has a unit in Visakhapatnam, which also went through regulatory inspections.
During the recent Hudhud cyclone, the Srikakulam unit was partially impacted.
On Wednesday, the company’s scrip gained 0.8 per cent to ₹3,569.40.