IGMPI India



USFDA issues warning letter to Jubilant Lifesciences Ltd

Jubilant Lifesciences Ltd announced that it has received a warning letter from the USFDA for one of its manufacturing unit, Jubilant HollisterStier in Washington. This letter has been issued in view of violations of certain good manufacturing practice (GMP) norms as per the USFDA. As mentioned in the warning letter, the company needs to make corrections of the violations and confirm their compliance to GMP standards. Until then FDA may hold giving new drug application approvals and supplements listings.

As per the FDA requirement, the company will have to respond to this letter by 12th December this month. The response should contain the details of corrective actions and should identify that these actions have already being implemented. Also, enlisted should be the details of pending corrective actions that would be taken to comply with current good manufacturing practice standards (cGMP).

As per the companys announcement, this letter would not have any impact on the manufacturing, and sale or distribution of their products of this facility. The company is hopeful about resolving this mater by working closely with the FDA.