Item specifics

2021/12/27 - 2022/12/27
Certification bodies

Certificate description

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health andconsumer protection agency responsible for ensuring all human and animal drugs, medical devices,cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco andradiation emitting devices safe, and effective.FDA’s Office of Regulatory Affairs (ORA) is the lead office for all agency regulatory activities. ORAsupports the six FDA product centers by inspecting regulated products and manufacturers, conductingsample analyses on regulated products, and reviewing imported products offered for entry into theUnited States. In addition to executing its mission through its federal workforce, ORA also works withthe FDA Centers, who develop FDA wide policy on compliance and enforcement and ORA executes theannual commodity work plans. Over 5,000 ORA employees located in district offices, resident posts, and2laboratories, strategically located throughout the United States perform inspections and investigations(including criminal investigations), wharf exams, sample collections and analyses, and carry outenforcement activities, education, and outreach directly to consumers, industry representatives,importers, and shippers as well as other stakeholders across the nation. ORA also works with its federal,state, local, tribal, territorial, and foreign counterparts to further the agency’s mission. ORA is led by theAssociate Commissioner for Regulatory Affairs (ACRA).