CBER continues to monitor the safety and stability of biological products that have been approved. Manufacturers must report certain problems to FDA's Biological Product Deviation Reporting System. Manufacturers must also report and correct product problems within established timeframes. If a significant problem is detected, a manufacturer may need to recall a product or even stop manufacturing it. CBER encourages health professionals and members of the public to report problems with biological products to FDA's MedWatch and, for vaccines, to the Vaccine Adverse Event Reporting System (VAERS). | 
