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USFDA team inspects Dr Reddy’s AP plant
USFDA Team Inspects Dr Reddy’s AP Plant. Dr Reddy\'s Laboratories Limited received inspectional observations from the US Food and Drug Administration (USFDA) for one of its active ingredients(APIs) manufacturing plants located in Srikakulam district in Andhra Pradesh. The observations came after a team of the USFDA visited the site recently.
Hyderabad: Dr Reddy's Laboratories Limited received inspectional observations from the US Food and Drug Administration (USFDA) for one of its active ingredients(APIs) manufacturing plants located in Srikakulam district in Andhra Pradesh. The observations came after a team of the USFDA visited the site recently.
The company confirmed the development while stating that these observations will not impact the normal activity of the plant in any way.
"We have received nine inspectional observations from the USFDA 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.
