As outlined in 21 CFR 1.232, the following information is required for domestic and foreign
food facility registrations:
• Facility name, address, phone number, and emergency contact phone number;
• Preferred mailing address, if different from that of the facility;
• Parent company name, address, and phone number (if the facility is a subsidiary of the
parent company);
• All trade names the facility uses;
• Name, address, and phone number of the owner, operator, or agent in charge;
• Email address of the owner, operator, or agent in charge, unless FDA has granted a
waiver under 21 CFR 1.245;
• Applicable food product categories of any food manufactured/processed, packed, or held
at the facility, as identified on Form FDA 3537;
• The type(s) of activity at the facility for each food product category, as provided in 21
CFR 1.232(a)(8);
• 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, and telephone number, the individual who authorized submission of the
registration. In addition, the registration must identify the individual who authorized
submission of the registration by email address, unless FDA has granted a waiver under
21 CFR 1.245.
In addition, beginning October 1, 2020, the facility’s UFI recognized as acceptable by FDA will
be required to be submitted with the registration information (21 CFR 1.232(a)(2)). Each
registration submission must include the name of the individual submitting the registration. For
the paper option, the registration must also include the individual’s signature (see 21 CFR
1.230).
For a domestic facility, the registration must also include:
• The email address for the contact person of the facility;
• An emergency contact phone number and email address if different from the email
address for the contact person.
For a foreign facility, the registration must also include:
• The name, full address, phone number, and email address of the foreign facility’s U.S.
agent;
• An emergency contact phone number and email address.
