Reporting Adverse Events and Product Deviations

Biological Product Deviation Reporting

  • Reporting system for errors and accidents in manufacturing of products, including testing, processing, packing, labeling, or storage, or with the holding or distribution of a licensed biological product or a blood or a blood component, in which the safety, purity, or potency of a distributed product may be affected. Also includes deviations in manufacturing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) that relate to the prevention of communicable disease transmission or HCT/P contamination or unexpected events that may relate to the transmission or potential transmission of a communicable disease or may lead to HCT/P contamination.

Notification Process for Transfusion Related Fatalities and Donation Related Deaths

  • Instructions for notifying CBER about deaths related to blood transfusions or blood donations.

Vaccine Adverse Event Reporting System (VAERS)

  • Created by the Food and Drug Adminstration and the Centers for Disease Control, this system is used to report adverse events or side effects related to the administration of a vaccine.

FDA MedWatch

  • The purpose of the MedWatch program is to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify significant health hazards associated with these products.

Related Information

Updated: June 24, 2008