 "Dr Reddy's API plant receives USFDA's observations")
After a team of the US Food and Drug Administration (USFDA) visited Dr Reddy's Laboratories’ Srikakulam plant in Andhra Pradesh recently, the Hyderabad drug manufacturer has received inspectional observations from the USFDA for one of its active pharmaceutical ingredients (APIs) manufacturing plants at Srikakulam.
The company confirmed the development while stating that these observations would not impact the normal activity of the plant in any way.
“We have received nine inspectional observations from the US FDA after their visit to our API manufacturing facility in Srikakulam district. We will respond to the agency within stipulated timelines with our remedial plans and start implementing the necessary measures immediately,” the company spokesperson said in a statement.
According to the company, these observations are largely related to procedural and other compliances of the plant systems. “At this stage, production continues in the normal course and there is no implication on any activity at the plant,” the statement said. These inspectional observations are called 483 observations related to the deviations noticed in the standard manufacturing practices.
The US drug regulator team has also visited the Visakhapatnam manufacturing facility though the outcome of their inspection is yet to be known.
The company confirmed the development while stating that these observations would not impact the normal activity of the plant in any way.
“We have received nine inspectional observations from the US FDA after their visit to our API manufacturing facility in Srikakulam district. We will respond to the agency within stipulated timelines with our remedial plans and start implementing the necessary measures immediately,” the company spokesperson said in a statement.
According to the company, these observations are largely related to procedural and other compliances of the plant systems. “At this stage, production continues in the normal course and there is no implication on any activity at the plant,” the statement said. These inspectional observations are called 483 observations related to the deviations noticed in the standard manufacturing practices.
The US drug regulator team has also visited the Visakhapatnam manufacturing facility though the outcome of their inspection is yet to be known.