FDA requires all registered domestic and foreign food and dietary supplement facilities to renew their FDA registration every two years. This applies to all the facilities that manufacture, process, pack, or store food, beverages, or dietary supplements intended for consumption in the USA.
- Initial Registration: Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the US must register with FDA.
- Registration Renewal: FDA registration must be renewed between October 1 and December 31 of every even-numbered year. Next renewal period is October – December 2024.
- Purpose of FDA Registration: FDA registration helps the FDA to regulate food facilities effectively and share important information related to food safety.
- Penalties: FDA registrations that are not timely renewed get cancelled and shipments of such facilities are refused admission into US
Biennial renewal of food facility registration with the FDA is important for several reasons:
Up-to-date Information:
The biennial renewal process helps the FDA maintain accurate and up-to-date information about facilities. This includes the address, contact details, and the types of activities conducted at the facility. Accurate data is essential for the FDA to respond quickly in case of a food safety issue.
Food Safety:
The renewal process supports the FDA’s ability to monitor and inspect food facilities to ensure compliance with food safety standards. This is crucial for preventing foodborne illnesses and ensuring that food products entering the US market are safe for consumption.
Compliance with FSMA:
FSMA mandates the registration and regular renewal of food facilities. Failure to renew registration can lead to a facility being considered non-compliant, which may result in legal actions, such as the refusal of food shipments, or being prohibited from distributing food in the US.
Efficient Communication:
Up-to-date registration information helps ensure that the FDA can communicate efficiently with facilities in case of emergencies, such as recalls, outbreaks, or other food safety concerns. Efficient communication is key to mitigating risks and protecting public health.
Preventing Market Disruptions:
Timely renewal helps prevent disruptions in the supply chain. If a facility fails to renew, it may face legal or logistical hurdles that may prevent its products from entering the US market, causing potential losses and supply issues.
Liberty management Group Ltd. can help companies with FDA Registration and biennial registration renewal.
Namrata
Regulatory Consultant