Domestic and foreign establishments that manufacture, package, or label food, dietary supplements, OTC drugs or medical devices are required by law to register with the Food and Drug Administration (FDA).
To ensure public safety and the highest quality of food supplies in the United States, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (called the Bioterrorism Act for short) was enacted to prevent any manufacturing impurity-related emergencies.
As a result, domestic and foreign establishments that manufacture, package, or label OTC drugs or medical devices are required by law to register with the FDA. Likewise, manufacturers of dietary supplements are also required to register their facilities in accordance with the Bioterrorism Act before producing or selling any products.
NHP Consulting will provide essential guidance and expertise through this complex procedure to help make the paperwork effortless. Our team can also help with food facility registration, which is mandatory for food products sold in the USA.