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Roorkee facility of Jubilant Life Science gets warning letter from USFDA

Updated: 06 March 2019

A warning letter has been issued to Jubilant Life Sciences, Roorkee facility based in Uttarakhand. It has been told by the officials of Jubilant Life Sciences that this warning letter can lead to withhold of several new application approvals until all the issues will be addressed by the company. The inspection was done from 30 July 2018 to 08 August 2018. cGMP regulations with respect to finished pharmaceuticals were violated at the facility as per FDA officials. According to warning letter, manufacturing, packing, methods, controls are not as per cGMP which represents their drug products are adulterated as per section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

Thorough investigation of batch failure or unexplained discrepancy was not done by firm. Investigations related to consumer complaints and deviations were not appropriate. CAPA effectiveness, justification of root causes was not explained appropriately. Violations were repeated by the firm following their response after the previous FDA inspection. There was no proper process where in-process materials get tested and rejected by quality control unit during manufacturing process. It was recommended by FDA officials that firm needs to hire a cGMP consultant as repeat violations were observed.