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Regulatory action after Jubilant Life’s Roorkee Plant survey suggested by USFDA

Updated: Dec 18, 2018

As per a regulatory filing, a supervisory action has been suggested by US health regulator after completion of the examination of Roorkee manufacturing facility of drug firm Jubilant Life Sciences.

The company indicated in a BSE registration on Saturday that FDA has classified the scrutiny of Roorkee plant as “Official action indicated” which means that approval of the ongoing application or supplement from this lot can be repressed.

The official action suggested means that there would be regulatory or managerial action against a facility after the completion of the inspection, according to FDA.

Jubilant Life in reply to inspection done by USFDA at Roorkee facility of solid dosage formulations in August 2018 has said “The agency provided knowledge to categorize the inspection as OAI, which suggest that ongoing applications or supplements from this point can be delayed. It said “We think that this letter has been issued as a part of USFDA initiative to reply to the company within a time span of 90 days of the inspection, about the status. It also said “this will not have any effect on present income from this facility’s working.

It also added that the company can take up to 40 days for getting agency’s verdict demoted from being categorized as OAI. Furthermore, it also added that the organization is in the advancement of providing more updates of its remedial actions and is optimistic of a positive result.