As per 21 CFR 1.232, the following information is required for US and non-US food facility registrations:
- Facility name, address, phone number and email address
- DUNS number
- Preferred mailing address, phone number & email address, if different from facility
- Parent company name, address, phone number & email address (if the facility is a subsidiary of the parent company)
- Facility Emergency contact name, phone number & email address
- All alternate names the facility uses
- US Agent name, address, phone number & email address
- Name, address, phone number & email address of the owner, operator, or agent in charge
- Applicable food product categories of any food manufactured, processed, packed, or stored at the facility
- The types of activity at the facility for each food product category
- A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
- A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate. If the individual submitting the form is not the owner, operator, or agent in charge of the facility, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, phone number & email address, the individual who authorized submission of the registration.
Liberty Management Group Ltd. can help you with FDA registration & US Agent service.
Namrata
Regulatory Consultant