The US Food and Drug Administration (US FDA) has found what it calls nine “inspectional observations” at Unit VI of Dr Reddy’s Laboratories
The US Food and Drug Administration (US FDA) has found what it calls nine “inspectional observations” at Unit VI of Dr Reddy’s Laboratories’ Srikakulam plant. The apex regulator has through Form 483 sought explanation on the nine observations that are said to be procedural.
The plant, which manufactures active pharmaceutical ingredients (APIs) and bulk drugs, was visited by US FDA last week. Form 483 is used by the FDA to document and communicate concerns discovered during these inspections.
“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 said in an emailed response to a query by FE.
“These observations largely relate to procedural and other compliance of the plant systems. At this stage, production continues in the normal course and there is no implication on any activity at the plant,” a company official said. Dr Reddy’s also said it cannot comment on the number of Forms 483 received in the last 203 years. However, as a result of this audit, no production has been effected, it said.
“The 483 observations are unlikely to affect the production of the company and, therefore, it will continue as per normal routine,” Sarabjit Kour Nangra, VP – Research Pharma, Angel Broking, said.
FE had reported about the surprise check by the regulator at the chemical technical operation (CTO) unit VI, which manufactures both active pharmaceutical ingredients (APIs) and bulk drugs. The unit, set up in 1990, has a reaction volume capacity of over 570 KL, and is US FDA inspected and ISO-9001 certified.
FE Bureau
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