Contains Nonbinding Recommendations 
 
 
 
 
 
Registration of Food Facilities: 
What  You Need to Know  About 
the FDA Regulation:  Guidance 
for Industry 
 
 Small Entity Compliance Guide 
 
 
 
Office of Compliance, HFS-607 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740   
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm  
 
You may submit either electronic or written comments regarding this guidance at any time. 
Submit electronic comments to https://www.regulations.gov.   Submit written comments on the 
guidance to the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville,  MD 20852.  All comments should be identified  with the 
docket number listed in the notice of availability  that publishes in the Federal Register. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
 
 
 
May 2018 
  Contains Nonbinding Recommendations 
 
 
 
Registration of Food Facilities: 
What  You Need to Know  About 
the FDA Regulation:  Guidance 
1
for Industry  
 
 Small Entity Compliance Guide 
 
 
 
This guidance represents the current thinking  of the Food and Drug Administration  (FDA or we) on 
this topic.  It does not establish any rights for any person and is not binding  on FDA or the public.  
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations.  To discuss an alternative approach, contact the FDA staff responsible for this 
guidance as listed on the title page.  
 
 
 
 
 
I.  Introduction 
 
This is a revision of the guidance What You Need To Know About Registration of Food 
Facilities that was issued in December 2012.  We are issuing revised guidance because in the 
Federal Register of July 14, 2016 (81 FR 45911), we published  a final rule pertaining  to 
registration of food facilities entitled Amendments to Registration  of Food Facilities  (the final 
rule).  The final rule amends the regulations at 21 CFR Part 1, Subpart H (21 CFR 1.225 through 
1.245).  The final rule became effective on September 12, 2016.  This guidance reflects changes 
made by the final rule.  We also have made editorial changes for clarity. 
 
We have prepared this Small Entity Compliance  Guide (SECG) in accordance with section 212 of 
the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121,  as amended by 
Public Law 110-28).  This guidance document is intended to help small entities comply with the 
food facility registration  regulations set forth in 21 CFR, Part 1, Subpart H (21 CFR 1.225 through 
1.245).  These regulations are binding  and have the full force and effect of law. 
 
                                                             
1  This guidance has been prepared by the Office of Compliance, in the Center for Food Safety and Applied 
Nutrition, and the Office of Surveillance & Compliance, in the Center for Veterinary Medicine, at the U.S. Food and 
Drug Administration. 
  2  Contains Nonbinding Recommendations 
 
FDA's guidance documents, including  this guidance, do not establish legally  enforceable 
responsibilities.   Instead, guidances describe our current thinking  on a topic and should be viewed 
only as recommendations,  unless specific regulatory or statutory requirements are cited.  The use of 
the word should in FDA guidances means that something is suggested or recommended, but not 
required. 
 
 
II.  Background 
 
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism 
Act) (Pub. L. 107-188) added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C 
Act).   Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that 
manufacture, process, pack, or hold food for human or animal consumption  in the United States to 
register with FDA. 
 
On October 10, 2003, we issued an interim final rule (68 FR 58894) to implement  section 415 of 
the FD&C Act.  That rule established the food facility registration regulations in 21 CFR Part 1, 
Subpart H (21 CFR 1.225 through 1.243).  Previously, this guidance restated FDAs food facility 
registration regulations.  This guidance also served as FDAs SECG for 21 CFR Part 1, Subpart H.   
 
The FDA Food Safety Modernization  Act (FSMA), enacted on January 4, 2011, amended section 
415 of the FD&C Act to require that facilities  engaged in manufacturing,  processing, packing, 
or holding  food for consumption  in the United States submit additional  registration information 
to FDA, including  an assurance that FDA will be permitted to inspect the facility at the times 
and in the manner permitted by the FD&C Act.  Section 415 of the FD&C Act, as amended by 
FSMA, also requires food facilities required to register with FDA to renew such registrations 
every other year, and provides FDA with authority to suspend the registration of a food facility 
in certain circumstances. 
 
On July 14, 2016, we published  a final rule (81 FR 45912) that amended our food facility 
registration regulations to reflect, among other things, the FSMA amendments to section 415 of 
the FD&C Act.  Accordingly,  FDA has revised this guidance document intended to help small 
entities comply with 21 CFR Part 1, Subpart H (21 CFR 1.225 through 1.245). 
 
 
1 This guidance has been prepared by the Office of Compliance, in the Center for Food Safety and Applied 
Nutrition, and the Office of Surveillance & Compliance, in the Center for Veterinary Medicine, at the U.S. Food and 
Drug Administration. 
 
  3  Contains Nonbinding Recommendations 
 
 
 
 
III.  Discussion 
 
ABOUT REGISTRATION 
 
Food Facility Registration Requirement 
 
Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in 21 CFR 
1.227, for human or animal consumption  in the United States must register with FDA. 
 
Why Facility Registration Is Required 
 
Food facility registration will help FDA to: 
  Determine the location and source of a potential bioterrorism  incident or an outbreak of 
food- borne illness; and 
  Quickly notify facilities that may be affected. 
 
What It Costs 
 
There is no fee for registration,  registration renewal or updates to a registration. 
  4  Contains Nonbinding Recommendations 
 
 
 
HOW REGISTRATION AFFECTS YOU 
Which Facilities Must Register 
If your facility is in one of the following  food industry sectors, you must register your facility 
with FDA. 
 
 
Food Industry Sectors Affected 
 
  Domestic and foreign manufacturers or processors2 
 
  Domestic and foreign packers2 
 
  Domestic and foreign storage operations 2 
 
 
 
Foods Handled by More Than One Foreign Facility: 
If...  Then... 
A foreign facility that manufactures, processes,  Only the second foreign facility  is 
packs, or holds the food sends it to another  required to register with respect to 
foreign facility for further  that food. 
manufacturing/processing  (including  packaging) 
before the food is exported to the U.S. 
The second foreign facility performs only a  Both facilities must register. 
minimal  activity, such as putting on a label 
Any foreign facility packs or holds food after the  The foreign packer or holder must 
last foreign manufacturer/processor of the food  also register. 
 
 
                                                             
2 Domestic facilities must register whether or not food from the facility enters interstate commerce. 
  5  Contains Nonbinding Recommendations 
 
 
 
Food Included in the Regulation 
 
Registration pertains only to facilities  that manufacture/process, pack, or hold food, as defined in 
21 CFR 1.227, for consumption by humans or animals in the United States. 
 
The following  chart gives examples of the types of food that are included in or excluded from the 
food definition  in the facility registration regulation.  If your facility handles any of the 
included foods, it must be registered. 
 
INCLUDED Foods  EXCLUDED Foods 
  Dietary supplements and dietary ingredients    Food contact substances 
   
  Infant formula    Pesticides 
 
  Beverages (including  alcoholic beverages and 
bottled water) 
 
  Fruits and vegetables 
 
  Fish3 and seafood 
 
  Dairy products and shell eggs 
 
  Raw agricultural  commodities  for use as food 
or components of food 
 
  Canned and frozen foods 
 
  Bakery goods, snack food, and candy 
(including  chewing gum) 
 
  Live food animals 
 
  Food for animals (e.g., pet food, pet treats and 
chews, animal feed) 
 
Note:  A facility that manufactures/processes, packs, or holds only a food contact substance or 
pesticide is NOT required to register with FDA. 
                                                             
3 Facilities that process only fish of the order Siluriformes (i.e., catfish, tra, swai, and basa) and products derived from 
these fish are not required to register as these facilities are regulated exclusively throughout the entire facility by the 
United States Department of Agriculture (USDA).  See question B.6.2 from draft Food Facility Registration Questions 
and Answers (Seventh Edition): Guidance for Industry. 
  6  Contains Nonbinding Recommendations 
 
 
Facilities That Do Not Have to Register 
If your facility meets one of the following  descriptions,  it does NOT have to register with FDA. 
 
 
These Facilities DONT Have to Register 
  Private residences of individuals, even though food may be manufactured/processed, 
packed, or held in them. 
  Non-bottled water drinking water collection and distribution establishments and 
structures, such as municipal  water systems. 
  Transport vehicles that hold food only in the usual course of their business as 
carriers. 
  Primary production farm4  i.e., an operation under one management in one general 
(but not necessarily contiguous)  physical  location  devoted to the growing of crops, the 
harvesting  of crops (washing,  trimming  outer leaves, and cooling  produce are part of 
harvesting),  the raising  of animals  (including  seafood),  or any combination  of these 
activities. The term primary production  farm can include operations that pack or hold 
raw agricultural  commodities,  pack or hold processed food, or manufacture/process food 
under certain circumstances.   
  Secondary activities farm4 i.e., an operation, not located on a primary production farm, 
devoted to harvesting, packing,  and/or holding  of raw agricultural  commodities,  as long 
as certain ownership criteria are met. A secondary activities farm may also pack or hold 
processed food or manufacture/process food under certain circumstances. 
  Restaurants  i.e.,  facilities  that prepare and sell  food  directly  to  consumers  for 
immediate  consumption,  including  pet shelters, kennels,  and veterinary facilities  that 
provide food to animals. Facilities  that provide food to interstate conveyances, such as 
commercial  aircraft, or central kitchens that do not prepare and serve food directly  to 
consumers, are not restaurants for purposes of 21 CFR Part 1, Subpart H. 
                                                             
4 See the farm definition at 21 CFR 1.227.  Note that in January 2018, FDA issued a guidance document in 
which we stated that we intend to initiate a rulemaking that could change the definition of a farm.  We also 
stated that we do not anticipate that the rulemaking would result in an entity that currently is a farm becoming a 
facility.  See Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and 
Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs, accessible at 
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm590646.htm. 
 
  7  Contains Nonbinding Recommendations 
 
  Retail food  establishments5, such as grocery  stores,  convenience  stores,  vending 
machine  locations,  and certain  farm-operated  businesses,  that sell  food  directly  to 
consumers  as  their  primary function, meaning  that  annual  food  sales  directly  to 
consumers are of greater dollar value than annual sales to other buyers.  The term retail 
food establishment includes facilities  that manufacture, process, pack, or hold food if 
the establishments  primary function is to sell food from that establishment  directly to 
consumers.  A farm-operated business means a business that is managed by one or 
more farms and conducts manufacturing/processing  not on the farm(s).  Sale of food 
directly to consumers by a farm-operated business includes the sale of food directly to 
consumers at a roadside stand; through  a community  supported  agriculture  program; 
and at other such direct-to-consumer sales platforms, including  door-to-door sales, mail, 
catalog  and  Internet  order,  including  online  farmers  markets  and  online  grocery 
delivery; religious  or other organization  bazaars; and State and local fairs. In addition, 
sale of food directly  to consumers from an establishment  located on a farm includes 
sales  by  that  establishment  directly  to  consumers  at a  roadside  stand;  through  a 
community  supported agriculture  program; and at other such direct-to-consumer  sales 
platforms,  including  door-to-door  sales,  mail,  catalog  and Internet order,  including 
online  farmers markets and online  grocery delivery;  religious  or other organization 
bazaars; and State and local fairs. 
  Nonprofit food facilities, which are charitable entities that meet the terms of 
 501(c)(3) of the Internal Revenue Code and that prepare or serve food directly to the 
consumer or otherwise provide food or meals for consumption  by humans or animals 
in the United States.  This includes central food banks, soup kitchens, and nonprofit 
food delivery services. 
  Fishing vessels that do not process fish. Such fishing vessels may engage in practices 
other than processing, such as harvesting and transporting fish, and heading, eviscerating, 
or freezing fish solely to prepare the fish for holding  on board the vessel. 
  Facilities regulated exclusively and throughout the entire facility by the U.S. 
Department of Agriculture under one of its inspection acts, that is, facilities processing 
only meat, poultry, or egg products that are inspected by USDAs Food Safety and Inspection 
Service. 
   
                                                             
 
5 See the retail food establishment definition at 21 CFR 1.227. 
 
  8  Contains Nonbinding Recommendations 
 
 
When Must My Facility Register? 
 
Your facility must register before you begin manufacturing/processing,  packing, or holding  food 
for consumption  in the United States. 
 
How Often Must a Facility Register or Renew its Registration? 
 
A food facility is required to submit an initial  registration to FDA only once.  Section 415(a)(3) 
of the FD&C Act, as amended by section 102 of FSMA, requires your facility to renew its 
registration with FDA every other year during the period beginning  on October 1 and ending on 
December 31 of each even-numbered year. 
 
Is a Facility Required to Resubmit all of the Registration Information during the 
Biennial Renewal Process? 
 
No.  FDA has an abbreviated biennial  registration renewal process for a registrant of a facility that 
has not had any changes to its registration information  since the registrant submitted the previous 
registration,  registration renewal, or update for the facility. 
 
Who May Register a Facility? 
 
The owner, operator, or agent in charge of a facility,  or an individual  authorized by one of them, 
may register that facility.  
 
Foreign facilities  must designate a U.S. agent, who lives or maintains a place of business in the 
United States and is physically  present in the United States, for purposes of communication 
between the facility and FDA.  The U.S. agent also may be authorized to register the facility. 
 
What If Your Facility Fails to Register, Renew, or Update its Registration? 
 
Failure to register your facility,  renew your registration,  update required elements, or cancel 
registration in accordance with section 415 of the FD&C Act and applicable  regulations is a 
prohibited  act under the FD&C Act.  The Federal government can bring a civil action against 
persons who commit a prohibited  act, or it can bring a criminal  action in Federal court to prosecute 
persons who are responsible for the commission  of a prohibited  act, or both. 
 
FDA will consider a registration for a food facility to be expired if the registration is not renewed.  
FDA will consider a food facility with an expired registration to have failed to register in 
accordance with section 415 of the FD&C Act. 
 
If a foreign facility is required to register but fails to do so, food from that facility that is offered 
for import into the United States is subject to being held at the port of entry or a secure facility 
until the foreign facility  is registered. 
 
What if FDA cancels an expired registration for failure to renew? 
 
If FDA cancels your registration because FDA considers it to be expired and you continue to 
manufacture/process, pack, or hold food for consumption  in the United States and are subject to 
section 415 of the FD&C Act, you must re-register. 
  9  Contains Nonbinding Recommendations 
 
 
SUSPENSION OF REGISTRATION  
 
Can FDA suspend the registration of a food facility? 
 
Yes. Section 415(b) of the FD&C Act, as amended by FSMA, provides that FDA may by order 
suspend the registration of a food facility registered under section 415 in certain circumstances. 
 
When can FDA suspend the registration of a food facility registered under section 415 of 
the FD&C Act? 
 
FDA can suspend a food facilitys registration when FDA determines that: 
 
1.   Food manufactured, processed, packed, received, or held by a registered facility has a 
reasonable probability  of causing serious adverse health consequences or death to humans or 
animals (SAHCODHA); and 
2.   A facility: 
a.  Created, caused or was otherwise responsible for that reasonable probability  of 
SAHCODHA; or 
b.  Knew of, or had reason to know of, the reasonable probability  of SAHCODHA, and 
packed, received, or held such food (section 415(b) of the FD&C Act). 
 
When are registered food facilities subject to the suspension of registration provisions of 
section 415 of the FD&C Act? 
 
Registered facilities became subject to the suspension of registration provisions  in section 415(b) 
of the FD&C Act on July 3, 2011, which was 180 days after the January 4, 2011 enactment of 
FSMA (section 415(b)(6)(B) of the FD&C Act). 
 
What is the effect of an order suspending a food facilitys registration? 
 
If the registration of a food facility is suspended under section 415(b) of the FD&C Act, no 
person can import or export food into the United States, offer to import or export food into the 
United States, or otherwise introduce food into interstate or intrastate commerce in the United 
States from such facility (section 415(b)(4) of the FD&C Act). 
 
Who may issue an order to suspend a food facilitys registration? 
 
The authority to issue an order to suspend a registration or to vacate an order of suspension may 
not be delegated by the Secretary of Health and Human Services to any officer or employee other 
than the FDA Commissioner  (section 415(b)(7) of the FD&C Act). 
 
If a facilitys registration is suspended, does the registrant have an opportunity for an 
informal hearing? 
 
FDA will  provide the registrant subject to a suspension  order with an opportunity  for an informal 
hearing. If a request for a hearing is granted, the hearing must be held as soon as possible  but not 
later than two business days after the issuance of the suspension order or such other time 
period as agreed upon by FDA and the registrant. Further, the hearing will  be on actions required 
for reinstatement of registration and why the registration that is subject to suspension should be 
  10  Contains Nonbinding Recommendations 
 
reinstated. FDA will reinstate a registration if it determines, based on evidence presented, that 
adequate grounds do not exist to continue the suspension of the registration (section 415(b)(2) of 
the FD&C Act). 
 
What happens if FDA determines that a suspension of registration remains necessary after 
providing opportunity for an informal hearing? 
 
FDA will require the registrant subject to a suspension order to submit a corrective action plan to 
FDA to demonstrate how the registrant plans to correct the conditions  found by FDA (section 
415(b)(3)(A) of the FD&C Act). 
 
When will FDA vacate an order suspending a food facilitys registration? 
 
FDA will vacate an order suspending a facilitys registration and reinstate the registration of the 
facility subject to the order, if FDA determines that adequate grounds do not exist to continue the 
suspension actions required by the order (sections 415(b)(2) and 415(b)(3)(B) of the FD&C Act). 
  11  Contains Nonbinding Recommendations 
 
 
REGISTERING YOUR FACILITY 
How to Register Your Facility 
Registrants must use Form FDA 3537 to register, renew, or update a registration.  This form is 
available online and in paper form.   
 
FDA will process paper submissions in the order received. 
 
 
 Note:  FDA does not allow registration in person. 
 
 
 
Online Registration 
You can save time by registering online at http://www.fda.gov/furls .  This web site offers online 
help and operates 24 hours a day, seven days a week. You can access the site wherever the Internet 
is available  including  libraries,  copy centers, schools, and Internet cafes. 
 
A Registration Help Desk is available on business days, from 7:00 AM until  11:00 PM U.S. 
Eastern Standard Time to help you. 
 
To Contact the Registration Help Desk: 
 By phone   WITHIN THE U.S.: Call 1-800-216-7331 or  240-247-8804 
 
 OUTSIDE THE U.S.: Call 240-247-8804 
 By fax   Fax questions to 301-436-2804 
 Furls@fda.gov or go to https://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.cfm   
 By email 
and complete the form 
 
Paper Registration 
If your facility does not have reasonable access to the Internet, you can request a copy of Form FDA 
3537 from FDA by mail or phone.  The form can be mailed or faxed to you. Fill  out the form 
completely and legibly  and mail it or fax it to:  
 
To Submit a Paper Registration: 
Send to: 
 By mail 
U.S. Food and Drug Administration 
Food Facility Registration 
HFS-681 
5001 Campus Drive 
College Park, MD  20740 
USA 
 By fax   301-436-2804 
   
Electronic submissions 
Beginning  January 4, 2020, registrants must submit registrations, registration renewals, updates, or 
cancellations to FDA electronically,  unless FDA has granted a waiver under 21 CFR 1.245 (see 21 
CFR 1.231(a)(2) and (b), 1.234(d), and 1.235(d)). 
  12  Contains Nonbinding Recommendations 
 
 
Waivers from Electronic Submissions 
If you are submitting  a waiver from electronic submission  of your registration, registration 
renewal, update, or cancellation,  you must submit a written request to FDA that explains why it is 
not reasonable for you to submit a registration,  registration renewal, update, or cancellation 
electronically  to FDA.  Possible reasons for why it may not be reasonable will depend on the 
circumstances, but in some cases may include conflicting  religious  beliefs or lack of reasonable 
access to the Internet.  (21 CFR 1.245) 
 
We encourage registrants seeking a waiver to submit their request in advance of the biennial 
registration renewal because we experience an increased volume of industry queries during this 
timeframe.   
 
To Request the Form: 
By mail  Write to: 
U.S. Food and Drug Administration 
Food Facility Registration 
HFS-681 
5001 Campus Drive 
College Park, MD  20740 
USA 
By phone  Call 1-877-216-7331  or 240-247-8804 (7:00 a.m. to 11:00 p.m. U.S. Eastern Standard Time) 
Note:  Paper registration is less efficient than online registration. It takes longer to receive 
confirmation for paper registration. And, if your form contains omissions or errors, FDA will 
return it for corrections without registering your facility resulting in further delay. 
  13  Contains Nonbinding Recommendations 
 
 
Information Required for Registration 
FDA requires you to provide the following  information  for facility registration. 
 
 
Required Information 
 
  Facility  name, full address, phone number 
 
  Beginning  October 1, 2020, the facilitys unique facility identifier (UFI) recognized as 
acceptable by FDA 
 
  The preferred mailing  address, if different from that of the facility 
 
  Parent company name, address, and phone number (if applicable) 
 
  Email address for the contact person of the facility  or, in case of a foreign facility,  the 
Name, address, phone number, and email address of the U.S. Agent for the facility 
 
  An emergency contact phone number and email address (for domestic facilities,  the email 
address is only required if this is different from the contact person) 
 
  Name, full address and phone number of the owner, operator, or agent in charge. In 
addition,  the email address of the owner, operator, or agent in charge is required, unless 
FDA has granted a waiver under 21 CFR 1.245 
   
  All trade names the facility uses 
 
  Applicable  food product categories, as listed on the registration form 
 
  The type of activity conducted at the facility for each food product category identified 
 
 
  Assurance that FDA will be permitted to inspect the facility at the times and in the 
manner permitted by the FD&C Act 
 
  Certification that the information  submitted is true and accurate and that the person 
submitting  it is authorized to do so 
 
 
   
  14  Contains Nonbinding Recommendations 
 
 
Optional Registration Information 
FDA also requests optional registration  information.   Although  you are not required by law to 
comply with this request, FDA encourages you to do so because such information  will  enable 
FDA to communicate more effectively with facilities that may be the target of, or otherwise 
affected by, a food-related emergency and such communication  will benefit FDA and the 
registered facility. 
 
 
Optional Information Requested 
 
  Facility  fax number 
 
  Fax number and e-mail address for the preferred mailing  address, if different from that 
 of the facility 
 
  Fax number of the owner, operator, or agent in charge of the facility 
 
  Fax number and email address of the parent company (if applicable) 
 
  Individual  name and title for the facility  emergency contact 
 
  For a foreign facility:  Title and fax number of its U.S. agent 
 
  Fax number of the authorizing  individual 
 
  Approximate dates of operation (if the facility's business is seasonal)
  15  Contains Nonbinding Recommendations 
 
 
Facility Registration Screen 
Here is a sample screen from the FDA registration web site ( http://www.fda.gov/furls). 
 
 
 
 
How Registration Is Confirmed 
After you register your facility,  FDA will confirm the registration,  perform certain 
verification  procedures and assign a registration number. 
 
How will FDA conduct the verification process for the unique facility identifier (UFI) 
required in the facilitys registration? 
 
Under 21 CFR 1.232(a)(2), domestic and foreign facilities must submit a unique facility 
identifier (UFI) recognized as acceptable to FDA in the facilitys registration (see also section 
F.2 of this document for further discussion of the UFI requirement). 
 
Please note, however, that the requirement for providing  a UFI in food facility registration 
submissions  will not begin until October 1, 2020. 
 
As outlined  in 21 CFR 1.231(a)(3) and (b)(5), beginning  October 1, 2020, FDA intends to 
conduct the verification  process for the UFI as follows: 
  16  Contains Nonbinding Recommendations 
 
 
  For electronic registrations,  after you submit your registration,  FDA will  verify the accuracy of 
your UFI recognized as acceptable by FDA and will also verify that the facility-specific  address 
associated with the UFI is the same address associated with your registration.   FDA will not 
confirm your registration or provide you with a registration number until  FDA verifies the 
accuracy of your facilitys UFI and verifies that the facility-specific  address associated with the 
UFI is the same address associated with your registration. 
  For electronic registration renewals, after you submit your electronic registration renewal, FDA will 
provide you with an electronic confirmation  of your registration renewal. When you add or update 
your facilitys UFI as part of the registration renewal, FDA will verify the accuracy of your 
facilitys UFI and will also verify that the facility-specific  address associated with the UFI is the 
same address associated with your registration. FDA will  not provide you with a confirmation  of 
your registration renewal until  FDA verifies the accuracy of your UFI and verifies that the facility-
specific address associated with the UFI is the same address associated with your registration. 
  For registrations submitted by mail or fax, after you submit your registration,  FDA will  verify the 
accuracy of your facilitys UFI and will also verify that the facility-specific  address associated 
with the UFI is the same address associated with your registration. FDA will not confirm your 
registration or provide you with a registration number until FDA verifies the accuracy of your 
facilitys UFI and verifies that the facility-specific  address associated with the UFI is the same 
address associated with your registration. 
  For registration renewals submitted by mail or fax, after you submit your registration renewal, 
FDA will provide you with a confirmation  of your registration renewal.  When you add or update 
your facilitys UFI as part of your registration renewal, FDA will verify the accuracy of your 
facilitys UFI and will also verify that the facility-specific  address associated with the UFI is the 
same address associated with your registration. FDA will  not provide you with a confirmation  of 
your registration renewal until  FDA verifies the accuracy of your UFI and verifies that the facility-
specific address associated with the UFI is the same address associated with your registration. 
 
Verification Procedures for Submissions Not Made by the Owner, Operator, or Agent in 
Charge of the Facility 
 
How will FDA conduct the verification process for submissions not made by the 
owner, operator, or agent in charge of the facility? 
 
For registrations or registration renewals not submitted by the owner, operator, or agent in charge of 
the facility,  FDA will verify that the individual  identified  as having authorized the submission  in 
fact authorized the submission  on behalf of the facility.  FDA will not confirm a registration, 
provide a registration number, or provide confirmation  of a registration renewal until that individual 
confirms that he or she authorized the submission  (see 21 CFR 1.231(a)(4) and (b)(6)).  In most 
circumstances, FDA will conduct this verification step by sending an email to the individual 
identified  as having authorized the submission.   In some circumstances, however, FDA may 
determine that it is appropriate to use other methods to conduct the verification step, such as U.S. 
mail or phone. 
 
For updates and cancellations,  FDA will not provide a confirmation  of the registration update or 
cancellation until the individual  confirms that he or she authorized the submission  (21 CFR 
1.234(c)(3) and (d)(6) (for updates) and 1.235(c)(3) and (d)(6) (for cancellations)).  We will 
provide the owner, operator, or agent in charge of the facility 30 calendar days to respond to our 
verification  request. 
 
If we do not receive a response to our verification  request within that time, the registration, 
  17  Contains Nonbinding Recommendations 
 
registration renewal, update, or cancellation submission  will be removed from our database and a 
new submission  will be required.  For registration renewals, updates, or cancellations, if FDA has 
previously  verified that the authorizing  individual  has authorized the individual  submitting  the 
renewal to make registration submissions  on behalf of the facility,  FDA will not re-verify that the 
authorizing  individual  in fact authorized the submission. 
 
FDA will continue its current practice of individually  contacting facilities if specific questions 
arise regarding the facilitys registration. 
 
Verification Procedures for U.S. Agents 
 
How will FDA conduct the verification process for U.S. agents? 
 
For registrations,  registration renewals, and updates to information  about U.S. agents, FDA will 
verify that the person identified  as the U.S. agent for the foreign facility agreed to serve as the 
U.S. agent (see 21 CFR 1.231(a)(5) and (b)(7) (for registrations and registration renewals) and 
1.234(c)(2) and (d)(5) (for updates)).  FDA will not confirm a registration or registration renewal 
or provide a registration number until the person identified  as the U.S. agent for the foreign 
facility confirms that the person agreed to serve as the U.S. agent (21 CFR 1.231(a)(5) and (b)(6)).  
For updates, FDA will not provide a confirmation  of the registration update until  the person 
identified  as the U.S. agent for the foreign facility confirms that the person agreed to serve as the 
U.S. agent (21 CFR 1.234(c)(2) and (d)(5)). 
 
In most circumstances, FDA will conduct this verification  step by sending an email to the person 
identified  as the U.S. agent.  In some circumstances, however, FDA may determine that it is 
appropriate to use other methods to conduct the verification step, such as U.S. mail or phone. 
 
If the individual  listed as the U.S. agent informs FDA that he has not agreed to serve as the 
facilitys U.S. agent, FDA will inform the facility (through its owner, operator, or agent in charge) 
of that fact and request that the facility amend the registration to designate an individual  who has 
agreed to serve as the facilitys U.S. agent.  For registration renewals, if FDA has previously 
verified that the U.S. agent has agreed to serve as the U.S. agent for the facility,  FDA will not re-
verify that the U.S. agent has agreed to serve as the U.S. agent for the foreign facility. 
 
We will provide the person identified  as the U.S. agent 30 calendar days to respond to our 
verification  request.  If we do not receive a response to our verification request within that time, 
the registration,  registration renewal, or update submission  will be removed from our database and 
a new submission  will  be required. 
 
Note:  Assignment of a registration number means only that the facility is registered.  It does 
NOT convey FDA approval or endorsement of the facility  or its products. 
 
Confidentiality of Registration Information 
The list of registered facilities and certain registration-related  information  are not subject to 
disclosure under the Freedom of Information Act (see section 415(a)(5) of the FD&C Act).  The 
provision  of section 415(a)(5) does not apply if the information  was obtained by FDA by other 
means or if the information  has previously  been lawfully disclosed to the public. 
 
 
How to Update Registration Information 
If any of the required information  on your registration form changes  for example, if there is a 
  18  Contains Nonbinding Recommendations 
 
new operator, agent in charge, or U.S. agent  the owner, operator, or agent in charge, or an 
individual  authorized by one of them, must notify FDA within 60 days (21 CFR 1.234(a)). 
 
To Update Your Registration: 
Online  Go to http://www.fda.gov/furls.6 
By paper  Use the paper registration process described on page 12 
 
In the case of new ownership, the former owner must cancel the facilitys registration within 60 
days and the new owner must register the facility  (21 CFR 1.234(b)). 
 
How to Cancel Registration 
If your facility goes out of business or comes under new ownership, you must cancel its registration 
within 60 days using Form FDA 3537a (21 CFR 1.235). You can do this electronically  at 
http://www.fda.gov/furls,  or you can request the form from FDA and use the paper registration 
process described on page 12. 
 
 
 
FIND OUT MORE 
 
How to Get More Information 
Additional  information  is available at  
https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm 
and http://www.fda.gov/Food/FoodSafety/FSMA/default.htm. 
 
 
 
 
 
 
 
 
 
 
 
 
                                                             
6 Use the PIN that was issued with your facilitys registration number.  If you originally registered by paper, you will 
need to follow the online instructions to set up an account. 
 
  19  Contains Nonbinding Recommendations 
 
 
 
FDAs Food Facility Registration Regulation At-a-Glance 
 
WHAT It Is: Domestic and foreign facilities that manufacture, process, pack, or hold food, as 
defined in 21 CFR 1.227, for human or animal consumption  in the U.S. must register with 
FDA. 
 
WHY Its Required: To help FDA to determine the location and source of a potential  or actual 
bioterrorism  incident or an outbreak of food-borne illness,  and permit the Agency to notify 
quickly  facilities that may be affected. 
 
WHICH Facilities Must Register: Domestic and foreign food manufacturers/processors, 
packers, and storage operations that handle food for consumption  in the U.S.  For purposes of 
registration,  food is defined in 21 CFR 1.227. 
 
 
Examples of WHICH Foods Require Facility Registration: 
  Dietary supplements and dietary ingredients 
  Infant formula 
  Beverages (including  alcoholic beverages and bottled water) 
  Fruits and vegetables 
  Fish7 and seafood 
  Dairy products and eggs 
  Raw agricultural  commodities  for use as food or components of food 
  Canned and frozen foods 
  Bakery goods, snack food, and candy (including  chewing gum) 
  Live food animals 
  Food for animals (e.g., pet food, pet treats and chews, animal feed) 
 
WHEN Facilities Must Register:  Before your facility begins to manufacture, process, pack, or 
hold food for consumption  in the United States. 
 
WHO May Register: The owner, operator, or agent in charge of a facility,  or an individual 
authorized by one of them, may register that facility. 
 
Foreign facilities  must designate a U.S. agent, who lives or maintains a place of business in the 
U.S. and is physically  present in the U.S., for purposes of communication  between the facility 
and FDA.  The U.S. agent also may be authorized to register the facility. 
                                                             
7 Facilities that process only fish of the order Siluriformes (i.e., catfish, tra, swai, and basa) and products derived 
from these fish are not required to register as these facilities are regulated exclusively throughout the entire facility 
by the United States Department of Agriculture (USDA).  See question B.6.2 from draft Food Facility Registration 
Questions and Answers (Seventh Edition): Guidance for Industry. 
  20  Contains Nonbinding Recommendations 
 
 
 
 
 
HOW to Register: 
Online  Go to http://www.access.fda.gov/  (24 hours a day, 7 days a week). 
By Mail or Fax  1. Request Form FDA 3537 from FDA (Call 1-877-216-7331 or 240-247-8804 (7:00 a.m. to 11:00 p.m. 
U.S. Eastern Standard Time)) 
2. Mail or fax (Fax: 301-436-2804) completed form to: 
U.S. Food and Drug Administration 
HFS-681 
5001 Campus Drive 
College Park, MD 20740 
   
Get HELP:  (business days, 7:00 AM to 11:00 PM U.S. EST) 
By phone  WITHIN THE U.S.: Call 1-800-216-7331 or 240-247-8804 
OUTSIDE THE U.S.: Call 240-247-8804 
By fax  Fax questions to 301-436-2804 
By email  Email questions to furls@fda.gov 
 
WHAT Information is Required: 
  Facility name, full address, phone number  
  Beginning October 1, 2020, the facilitys unique facility identifier (UFI) recognized as acceptable by FDA 
  The preferred mailing address, if different from that of the facility 
  Parent company name, address and phone number (if applicable) 
  Email address for the contact person of the facility  or, in case of a foreign facility,  the name, address, phone 
number, and email address of the U.S. Agent for the facility 
  An emergency contact phone number and email address (for domestic facilities, the email address is only required if this 
is different from the contact person) 
  Name, full address and phone number of the owner, operator or agent in charge. In addition, the email address of the 
owner, operator, or agent in charge is required, unless FDA has granted a waiver under 21 CFR 1.245 
  All trade names the facility uses 
  Applicable food product categories, as listed on the registration form 
  The type of activity conducted at the facility for each food product category identified 
  Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act 
  Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so 
 
HOW Registration Is Confirmed: FDA confirms the registration either electronically (online registration) or by mail 
(paper), and assigns a registration number. 
WHAT IF... 
If...  Then... 
Required registration info changes  You must notify FDA within 60 days. 
Theres a change in ownership  The former owner must cancel registration within 60 days and the new owner must 
register. 
Your facility goes out of business  You must cancel registration. 
A domestic facility fails to register  The Federal government can bring a civil or criminal action against the owner, 
operator, or agent in charge. 
A foreign facility fails to register and  The food will be held at the port of entry, unless otherwise directed by FDA or 
then tries to import food into the U.S.  CBP. 
 
Get More Information:  For more information,  go to  
https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm 
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