Jubilant Life Sciences has been issued a warning letter (WL) for one of its manufacturing facility, Jubilant HollisterStier General Partnership (JHS) located at Kirkland, Quebec in Canada. The company has received WL from US Food and Drug Administration (USFDA) identifying significant violations of current Good Manufacturing Practices (cGMP) Regulations.
As required by USFDA, JHS will respond to this WL on or before March 15, 2013. The response will provide details as to what corrective action has already been completed, as well as, additional detail as to how the facility will prevent the reoccurrence of the items found to be objectionable to the USFDA.
USFDA specified in the WL that until all corrections have been completed and that they have confirmed correction of the violations and firm compliance to cGMPs, USFDA may withhold approval of new applications or supplements listing JHS as the drug product manufacturer.
The company expects that the on-going manufacturing, distribution and sale of products will not be affected by this WL. Besides, JHS is committed to implementing the necessary corrective actions required to address the USFDA concerns, and will work closely with the USFDA to bring resolution to this matter.
