Food Facility Registration is an FDA requirement for all domestic and foreign facilities that manufacture, process, pack, or hold human or animal food for consumption in the USA. US FDA can cancel or revoke a food facility registration under certain circumstances. If an FDA registered facility fails to meet the FDA’s requirements, the FDA has the authority to suspend or cancel that registration.
Common scenarios in which the FDA might cancel or suspend food facility registration:
- Failure to submit Registration correctly – FDA may cancel a registration if they find the information to be inaccurate or duplicate.
- Failure to renew Registration – Food facilities are required to renew their registration every two years. If a facility fails to do so, the FDA may cancel the registration. In such case, facilities must re-register prior to exporting.
- Failure to Comply with FDA Regulations – If a facility fails to comply with FDA regulations, such as food safety requirements or FSMA, the FDA may revoke or suspend its registration. Non-compliance could include violations like:
- Failing to meet sanitation standards.
- Inadequate hazard analysis and lack of proper food safety procedures.
- Failure to comply with the FSVP for foreign facilities.
- Failure to Respond to an FDA Inspection – If a facility undergoes an FDA inspection and the inspection reveals significant violations or non-compliance, the FDA can revoke or suspend the registration.
- Product Recalls or Serious Safety Issues – FDA may cancel a food facility’s registration if serious safety issues arise, such as the facility being involved in recalls, foodborne illness outbreaks, or repeated non-compliance with GMP regulations.
- Failure to Cooperate with FDA Investigations – If the FDA is conducting an investigation and the facility does not cooperate (e.g., not providing records or access to information), the FDA may suspend or cancel the facility’s registration.
Consequences of a Canceled or Suspended Food Facility Registration
If the FDA cancels or suspends a food facility’s registration, it has serious implications for the business:
- Inability to Import Food: A canceled or suspended registration means the facility cannot import food into the US until the registration is reinstated.
- Business Interruption: The facility will be unable to legally manufacture, process, pack, or hold food for U.S. consumption, which can significantly disrupt business operations.
- Legal and Financial Consequences: In some cases, a facility may face penalties, fines, or other legal consequences if its registration is canceled due to violations or non-compliance.
How to Avoid Cancellation of Food Facility Registration
- Timely renewal of your registration (every two years).
- Compliance with all applicable FDA regulations, including food safety practices, labeling requirements, and FSMA regulations.
- Proper documentation and recordkeeping
Liberty Management Group Ltd. can help you with FDA registration, re-registration, and renewals.
Namrata
Regulatory Consultant