USFDA recommends regulatory action after Jubilant Life Roorkee plant inspection
New Delhi: The US health regulator has recommended a regulatory or administrative action after the inspection of Roorkee manufacturing facility of drug firm Jubilant Life Sciences, according to a regulatory filing. The FDA has classified the inspection of the Roorkee plant as 'Official Action Indicated', which means approvals of pending applications or supplements from this site may be withheld, the company said in a BSE filing on Saturday.
According to the FDA, Official Action Indicated means regulatory and/or administrative actions will be recommended against a facility after an inspection.
In response to the USFDA inspection conducted at the Roorkee facility of solid dosage formulations during August 2018, "the agency has informed to classify the inspection as OAI and that approvals of pending applications or supplements from this site may be withheld," Jubilant Life said.
However, this will not have any impact on the existing revenues from operations from this facility, it added.
"We believe that this letter has been issued as part of USFDA initiative to respond to the company within 90 days of the inspection, regarding the status," it said.
As per the guidelines, the company can engage within 40 days to get the agency's decision downgraded from classifying as OAI, it added.
The company "is in the process of sending further update of its corrective actions and remains hopeful of a positive outcome, " it said.
BSEcorrective actionsfilingformulationinspectionJubilant Lifejubilant life scoaipharmapharmaceuticalregulationregulatoryRoorkee plantsitesolid doseUSFDA
Source : PTIFarhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
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