and U.S. Agent
FDA registration is required for all facilities that manufacture, process, pack, or store dietary supplements that may be consumed in the United States by humans or animals. Companies located outside the United States must designate a U.S. Agent for FDA communications.
Prior Notice is required before dietary supplement shipments may enter the United States. A bar-coded Prior Notice Confirmation Number issued by FDA must accompany most shipments.
Labeling errors are one of the leading causes of FDA detentions. Registrar Corp helps companies modify their dietary supplement labeling to comply with FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents.
Dietary supplement manufacturers must prepare and follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size of dietary supplements they manufacture to ensure uniformity in the finished batches. Registrar Corp’s Food Safety Specialists can review your Master Manufacturing Record for FDA compliance.
Adverse Event Contact
U.S. FDA requires dietary supplement labels to bear a United States address or phone number to receive consumer reports of serious adverse events. Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA.
Color Additive Regulations
A color additive is any dye, pigment, or other substance that can impart color to a dietary supplement. Color additives for supplements are regulated by FDA.
Dietary supplements are subject to examination by FDA when imported into the United States. Registrar Corp provides immediate assistance for companies with products detained at the port of entry by FDA, include those subject to DWPE due to an FDA Import Alert.