USFDA recommends regulatory action after Jubilant Life’s 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 maybe withheld, the company said in a BSE filing 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 maybe 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.

  • Related Posts

    • Pharma
    • March 27, 2024
    • 105 views
    Spurious drugs: Maiden Pharma blacklisted, all contracts cancelled

    Haryana has blacklisted Maiden Pharmaceuticals Ltd, based at Sonepat, for three years, thereby debarring the firm from participating in state tenders. All rate contracts issued to the firm have also…

    • Pharma
    • March 27, 2024
    • 69 views
    DCC Calls For Strict Implementation Of Revised Schedule M, State-Level Activities To Address AMR

    New Delhi: The Drugs Consultative Committee (DCC), the advisory committee formed by the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Spurious drugs: Maiden Pharma blacklisted, all contracts cancelled

    Spurious drugs: Maiden Pharma blacklisted, all contracts cancelled

    DCC Calls For Strict Implementation Of Revised Schedule M, State-Level Activities To Address AMR

    DCC Calls For Strict Implementation Of Revised Schedule M, State-Level Activities To Address AMR

    Sanofi, Cipla Join Hands To Expand Reach Of CNS Portfolio In India

    Sanofi, Cipla Join Hands To Expand Reach Of CNS Portfolio In India

    Cyberabad Police Seize 1 Kg Alprazolam, Arrest Three

    Cyberabad Police Seize 1 Kg Alprazolam, Arrest Three

    Lee Health develops natural capsule for effective Heart care

    Lee Health develops natural capsule for effective Heart care

    Medical Shop Run By Twenty20 In Kizhakkambalam Asked To Shut Down

    Medical Shop Run By Twenty20 In Kizhakkambalam Asked To Shut Down