New Delhi, Dec 31, 2014: The facilities which produce FDA regulated drugs require to register with US FDA and renew their registrations according to defined time frame. The last date to renew the registration by Food and beverage, drug, and medical device facilities is December 31, 2014, which means only 2 days are left to renew the registrations.
If the facilities fail to renew their registrations then FDA can take civil or criminal action as failure to renewal is a prohibited act.
According to FDA, food facilities that manufacture, process, pack, or store food intended for consumption in the USA require to renew their registrations each year in even numbered months between October 1 and December 31.Failing to do so, food facility will be required to create new FDA registration as the existing registration will be considered expired by FDA. The expired facility will be deleted from the FDA system in early 2015 and if such facilities continue to ship food products to U.S. in 2015 they will be stopped at the U.S. border due to lack of registration. The food products will be held at the border or will be shipped to a safer place until a valid registration is obtained from the facility responsible for food.
Similarly drug facilities responsible for manufacturing, preparing, compounding and processing of drugs which are commercially distributed or imported in USA must renew their registrations every year between October 1 and December 31.In case the facilities fail to do so then their drugs will be considered misbranded and distribution in U.S. will be considered illegal. Medical device facilities also require to renew their registrations between October 1 and December 31 every year and failing to do so will make FDA consider devices manufactured from such facilities as misbranded.IGMPI(http://www.igmpiindia.org/)
