Company claimed that observations relate to procedural and other compliances of the plant systems
US health regulator Food and Drug Administration (FDA) has procedural deviations at Dr Reddy's Laboratories manufacturing plant at Srikakulam
Hyderabad: US health regulator Food and Drug Administration (FDA) has procedural deviations at Dr Reddy’s Laboratories manufacturing plant at Srikakulam.While confirming the FDA observations during a recent inspection, the Hyderabad-based pharmaceutical company said that it would respond to the regulator shortly.“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 timeline with our remedial plans and start implementing the necessary measures immediately,” a company spokesperson said in a statement.Ruling any impact on the functioning of the plant, the company claimed that observations relate 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.
According to analysts, the company received ‘Form 483’ observations from USFDA for its unit 6 of Vizag plant.As per FDA website, during an inspection, FDA’s Office of Regulatory Affairs investigators may observe conditions they deem to be objectionable.These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that a product may be in violation of FDA norms.
The plant, which manufactures active pharmaceutical ingredients and bulk drugs, was visited by the US FDA last week.“According to the company, 483 observations are unlikely to affect the production of the company and therefore, it will continue as per normal routine,” said Sarabjit Kour Nangra, vice-president, research pharma, Angel Broking.
( Source : dc correspondent )
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