Form FDA 3537 FDA 3537 Food Facility Registration

Form Approval: OMB No. 0910-0502; Expiration date: MM/DD/YYYY; See OMB Statement on page 6.
FDA USE ONLY

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

DHHS/FDA FOOD FACILITY REGISTRATION
(If entering by hand, use blue or black ink only.)
Date (mm/dd/yyyy)

Section 1 - TYPE OF REGISTRATION
1a.

DOMESTIC REGISTRATION

FOREIGN REGISTRATION

1b.

INITIAL REGISTRATION

UPDATE OF REGISTRATION INFORMATION

1c.

BIENNIAL REGISTRATION RENEWAL

ABBREVIATED REGISTRATION RENEWAL (Complete Section
12)
By checking this box, you are certifying that no changes have been made to your registration

If update or registration renewal, provide the Facility Registration
Number and PIN
For update of registration information: Check all that apply and further
identify changes in the applicable sections

Facility Registration Number

PIN

United States Agent Change - Foreign facilities only

Facility Name Change

Seasonal Facility Dates of Operation Change

Facility Address Change (See instructions)

Type of Activity Change

Preferred Mailing Address Change

Human Food Product Category Change

Parent Company Change

Animal Food Product Category Change

Emergency Contact Change

Operator or Agent in Charge Change

Trade Name Change
1c. ARE YOU THE NEW OWNER OF A PREVIOUSLY REGISTERED FACILITY?
If "Yes", provide the following information, if known.
Previous owner's name

Yes

No

Previous owner's registration number

Section 2 - FACILITY NAME / ADDRESS INFORMATION
Facility Name
Facility Street Address, Line 1
Facility Street Address, Line 2
City

State (If applicable; if not, skip to Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)

Domestic Facility Contact Person E-Mail Address

FORM FDA 3537 (6/2016)

PAGE 1 OF 6

Section 3 - PREFERRED MAILING ADDRESS INFORMATION - Complete this section if different from Section
2 Facility Name/Address Information
If information is the same as section 2, check the box:
Name
Street Address, Line 1
Street Address, Line 2
City

State (If applicable; if not, skip to
Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Optional; Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)

E-Mail Address (Optional)

Section 4 - PARENT COMPANY NAME / ADDRESS INFORMATION (If applicable and if different
from Sections 2 and 3)
If information is the same as another section, check which
section:

Section 2

Section 3

Name of Parent Company
Street Address of Parent Company, Line 1
Street Address of Parent Company, Line 2
City

State (If applicable; if not, skip to
Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)

E-Mail Address (Optional)

Section 5 - FACILITY EMERGENCY CONTACT INFORMATION
For foreign facilities, FDA will use your U.S. agent as your emergency contact unless you choose to designate a different
contact here.
If information is the same as another section, check which
section:
Individual Name (Optional)

Section 2

Section 7

Title (Optional)
E-Mail Address
FORM FDA 3537 (6/2016)

Emergency Contact Phone (Include Area/Country
Code)
PAGE 2 OF 6

Section 6 - TRADE NAMES - If this facility uses trade names other than that listed in Section 2 above, list
them below (e.g., "Also doing business as," "Facility also known as").
Alternative Trade Name #1
Alternative Trade Name #2
Alternative Trade Name #3
Alternative Trade Name #4

Section 7 - UNITED STATES AGENT - To be completed by facilities located outside any State or Territory of
the United States, the District of Columbia, or the Commonwealth of Puerto Rico
Name of U.S. Agent
Title (Optional)
Address, Line 1
Address, Line 2
City

State

ZIP Code

U.S. Agent Phone Number (include Area Code)

Emergency Contact Phone Number (Includes Area Code)

FAX Number (Optional; Include Area Code)

E-Mail Address

Section 8 - SEASONAL FACILITY DATES OF OPERATION (OPTIONAL)
Optional - Give the approximate dates that your facility is open for business, if its operations are on a seasonal basis.
Dates of Operation (mm/dd/yyyy)

FORM FDA 3537 (6/2016)

PAGE 3 OF 6

Section 9a - GENERAL PRODUCT CATEGORIES - FOOD FOR HUMAN CONSUMPTION; and TYPE OF ACTIVITY CONDUCTED AT THE FACILITY

To be completed by all food facilities. Please see instructions for further examples.

IF NONE OF THE MANDATORY CATEGORIES BELOW APPLY, SELECT BOX 37.

TYPE OF ACTIVITY CONDUCTED AT THE FACILITY - Check all types of operations that are performed at this facility regarding the
manufacturing/processing, packing or holding of human food.
Ambient Food
Refrigerated Food
Frozen Food
Storage Warehouse
Storage Warehouse
Storage Warehouse
/ Holding Facility
/ Holding Facility
/ Holding Facility
(e.g., storage
(e.g., storage
(e.g., storage
facilities, including
facilities, including
facilities)
storage tanks, grain
storage tanks)
elevators)

1. ALCOHOLIC BEVERAGES [21 CFR 170.3 (n) (2)]
2. BABY (INFANT AND JUNIOR) FOOD PRODUCTS Including Infant Formula
3. BAKERY PRODUCTS, DOUGH MIXES, OR ICINGS [21 CFR 170.3 (n) (1), (9)]
4. BEVERAGE BASES [21 CFR 170.3 (n) (3), (35)]
5. CANDY WITHOUT CHOCOLATE, CANDY SPECIALTIES AND CHEWING GUM
[21 CFR 170.3 (n) (6), (9), (25), (38)]
6. CEREAL PREPARATIONS, BREAKFAST FOODS, QUICK COOKING / INSTANT
CEREALS [21 CFR 170.3 (n) (4)]
7. CHEESE AND CHEESE PRODUCT CATEGORIES [21 CFR 170.3 (n) (5)]
a. Soft, Ripened Cheese
b. Semi-Soft Cheese
c. Hard Cheese
d. Other Cheeses and Cheese Products
8. CHOCOLATE AND COCOA PRODUCTS [21 CFR 170.3 (n) (3), (9), (38), (43)]
9. COFFEE AND TEA [21 CFR 170.3 (n) (3), (7)]
10. COLOR ADDITIVES FOR FOODS [21 CFR 170.3 (o) (4)]
11. DIETARY CONVENTIONAL FOODS OR MEAL REPLACEMENTS (Includes
Medical Foods) [21 CFR 170.3 (n) (31)]
12. DIETARY SUPPLEMENT CATEGORIES
a. Proteins, Amino Acids, Fats and Lipid Substances [21 CFR 170.3
(o) (20)]
b. Vitamins and Minerals
c. Animal By-Products and Extracts
d. Herbals and Botanicals
13. DRESSING AND CONDIMENTS
[21 CFR 170.3 (n) (8), (12)]
14. FISHERY / SEAFOOD PRODUCT CATEGORIES [21 CFR 170.3 (n) (13), (15),
(39), (40)]
a. Fin Fish, Whole or Filet
b. Molluscan Shellfish
c. Other Shellfish
d. Ready to Eat (RTE) Fishery Products
e. Processed and Other Fishery Products
15. FOOD ADDITIVES, GENERALLY RECOGNIZED AS SAFE (GRAS)
INGREDIENTS, OR OTHER INGREDIENTS USED FOR PROCESSING [21 CFR
170.3 (n) (42); 21 CFR 170.3 (o) (1), (2), (3), (5), (6), (7), (8), (9), (10), (11),
(12), (13), (14), (15), (16), (17), (18), (19), (22), (23), (24), (25), (26), (27), (28),
(29), (30), (31), (32)]
16. FOOD SWEETENERS (NUTRITIVE) [21 CFR 170.3 (n) (9) (41), 21 CFR 170.3
(o) (21)]
17. FRUIT AND FRUIT PRODUCTS [21 CFR 170.3 (n) (16), (27), (28), (35), (43)]
a. Fresh Cut Produce
b. Raw Agricultural Commodities
c. Other Fruit and Fruit Products
18. FRUIT OR VEGETABLE JUICE, PULP OR CONCENTRATE PRODUCTS [21
CFR 170.3 (n) (3), (16), (35)]
19. GELATIN, RENNET, PUDDING MIXES, OR PIE FILLINGS [21 CFR 170.3 (n)
(22)]
20. ICE CREAM AND RELATED PRODUCTS [21 CFR 170.3 (n) (20), (21)]
21. IMITATION MILK PRODUCTS [21 CFR 170.3 (n) (10)]
22. MACARONI OR NOODLE PRODUCTS [21 CFR 170.3 (n) (23)]
23. MEAT, MEAT PRODUCTS AND POULTRY (FDA REGULATED) [21 CFR 170.3
(n) (17), (18), (29), (34), (39), (40)]
24. MILK, BUTTER, OR DRIED MILK PRODUCTS [21 CFR 170.3 (n) (12), (30),
(31)]
25. MULTIPLE FOOD DINNERS, GRAVIES, SAUCES AND SPECIALTIES [21 CFR
170.3 (n) (11) (14), (17), (18), (23), (24), (29), (34), (40)]
26. NUTS AND EDIBLE SEED PRODUCT CATEGORIES [21 CFR 170.3 (n) (26),
(32)]
a. Nut and Nut Products
b. Edible Seed and Edible Seed Products
27. PREPARED SALAD PRODUCTS [21 CFR 170.3 (n) (11), (17), (18), (22), (29),
(34), (35)]
28. SHELL EGG AND EGG PRODUCT CATEGORIES [21 CFR 170.3 (n) (11), (14)]
a. Chicken Egg and Egg Products
b. Other Eggs and Egg Products
29. SNACK FOOD ITEMS (FLOUR, MEAL OR VEGETABLE BASE) [21 CFR 170.3
(n) (37)]
30. SPICES, FLAVORS, AND SALTS [21 CFR 170.3 (n) (26)]
31. SOUPS [21 CFR 170.3 (n) (39), (40)]
32. SOFT DRINKS AND WATERS [21 CFR 170.3 (n) (3), (35)]
33. VEGETABLE AND VEGETABLE PRODUCT CATEGORIES [21 CFR 170.3 (n)
(19), (36)]
a. Fresh Cut Products
b. Raw Agricultural Commodities
c. Other Vegetable and Vegetable Products
34. VEGETABLE OILS (INCLUDES OLIVE OIL) [21 CFR 170.3 (n) (12)]
35. VEGETABLE PROTEIN PRODUCTS (SIMULATED MEATS) [21 CFR 170.3 (n)
(33)]
36. WHOLE GRAINS, MILLER GRAIN PRODUCTS (FLOURS), OR STARCH [21
CFR 170.3 (n) (1), (23)]
37. IF NONE OF THE ABOVE FOOD CATEGORIES
APPLY, THEN PRINT THE APPLICABLE FOOD CATEGORY OR CATEGORIES
(THAT DOES NOT OR DO NOT APPEAR ABOVE).
Other Activity Conducted

FORM FDA 3537 (6/2016)

PAGE 4 OF 6

Acidified
Food
Processor

Low-Acid
Food
Processor

Interstate
Conveyance
Caterer /
Catering Point

Contract
Sterilizer

Labeler /
Relabeler

Other
Activity
Farm Mixed- Conducted
Manufacturer / Repacker /
Type
(Please
Packer
Processor
(Recondition
Facility
Specify
er)
Below
Row 37)
Salvage
Operator

Section 9b - GENERAL PRODUCT CATEGORIES - FOOD FOR ANIMAL CONSUMPTION; and TYPE OF ACTIVITY CONDUCTED AT THE FACILITY

TYPE OF ACTIVITY CONDUCTED AT THE FACILITY - Check all types of operations that are performed at this facility regarding the manufacturing/processing, packing or
holding of animal food.

To be completed by all animal food facilities. Please see instructions for
further examples.
IF NONE OF THE MANDATORY CATEGORIES BELOW APPLY, SELECT BOX 33.

Animal food
manufacturer /
Processor

Animal Food
Warehouse /
Holding Facility
(e.g., storage
facilities,
including
storage tanks,
grain elevators)

Acidified Food
Processor

Low Acid Food
Processor

Contract
Sterilizer

Packer /
Repacker

Labeler /
Relabeler

1. GRAIN OR GRAIN PRODUCTS (I.E., BARLEY, GRAIN
SORGHUMS, MAIZE, OAT, RICE, RYE, WHEAT, OTHER GRAINS OR
GRAIN PRODUCTS)
2. OILSEED OR OILSEED PRODUCTS (I.E., COTTONSEED,
SOYBEANS, OTHER OILSEEDS OR OILSEED PRODUCTS)
3. ALFALFA PRODUCTS OR LESPEDEZA PRODUCTS
4. AMINO ACIDS OR RELATED PRODUCTS
5. ANIMAL PROTEIN PRODUCTS
6. BOTANICALS AND HERBS
7. BREWER PRODUCTS
8.CHEMICAL PRESERVATIVES
9. CITRUS PRODUCTS
10. DIRECT FED MICROBIALS
11. DISTILLERY PRODUCTS
12. ENZYMES
13. FATS OR OILS
14. FERMENTATION PRODUCTS
15. FORAGE PRODUCTS
16. HUMAN FOOD BY-PRODUCTS NOT OTHERWISE LISTED
17. MARINE PRODUCTS
18. MILK PRODUCTS
19. MINERALS OR MINERAL PRODUCTS
20. MISCELLANEOUS OR SPECIAL PURPOSE PRODUCTS
21. MOLASSES OR MOLASSESS PRODUCTS
22. NON-PROTEIN NITROGEN PRODUCTS
23. PEANUT PRODUCTS
24. PROCESSED ANIMAL WASTE PRODUCTS
25. SCREENINGS
26. TECHNICAL ADDITIVES
27. VITAMINS OR VITAMIN PRODUCTS
28. YEAST PRODUCTS
29. MIXED FEED (E.G., POULTRY, LIVESTOCK, EQUINE)
30. PET FOOD
31. PET TREATS OR PET CHEWS
32. Pet Nutritional Supplements (e.g., vitamins, minerals)
33. IF NONE OF THE ABOVE FOOD CATEGORIES
APPLY, THEN PRINT THE APPLICABLE FOOD CATEGORY OR
CATEGORIES (THAT DOES NOT OR DO NOT APPEAR ABOVE).
Other Activity Conducted

Section 10 - OWNER, OPERATOR, OR AGENT-IN-CHARGE INFORMATION
Name of Entity or Individual Who Is the Owner, Operator, or Agent-in-Charge
Provide the following information, if different from all other sections on the form. If the information is the same as another section of the form, check which section.
SECTION 2

SECTION 3

SECTION 4

SECTION 7

Street Address, Line 1
Street Address, Line 2
City

State (If applicable; if not, skip to Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)
FORM FDA 3537 (6/2016)

E-Mail Address (Required unless FDA has granted a waiver under 21 CFR 1.245)
PAGE 5 OF 6

Other Activity
Salvage Operator Farm Mixed-Type
(Please Specify
(Reconditioner)
Facility
Below Row 33)

Section 11 - INSPECTION STATEMENT
FDA will be permitted to inspect the facility at the time and in the manner permitted by the Federal Food, Drug, and Cosmetic Act.

Section 12 - CERTIFICATION STATEMENT
The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility,
must submit this form. By submitting this form to FDA, or by authorized individual to submit this form to FDA, the owner, operator, or agent
in charge of the facility certifies that the above information is true and accurate. An individual (other than the owner, operator, or agent in
charge of the facility) who submits the form to the FDA also certifies that the above information submitted is true and accurate and that
he/she is authorized to submit the registration on the facility's behalf. An individual authorized by the owner, operator, or agent in charge
must below identify by name the individual who authorized submission of the registration. Under 18 U.S.C. 1001, anyone who makes a
materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.
Signature of Submitter
Printed Name of Submitter
Check One Box
A. INDIVIDUAL ASSOCIATED WITH THE INFORMATION IN SECTION 10 (STOP HERE, FORM IS COMPLETED)
B. ANOTHER AUTHORIZED INDIVIDUAL
INFORMATION ABOUT AUTHORIZING INDIVIDUAL (Required if Box B above is checked)
Authorizing Individual Name ___________________________________________
Address Information for the Authorizing Individual

Authorizing Individual Street Address, Line 1

Authorizing Individual Street Address, Line 2
City

State (If applicable; if not, skip to Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)

E-Mail Address (Required unless FDA has granted a waiver under 21 CFR 1.245)

MAIL COMPLETED FORM FDA 3537 TO U.S. FOOD AND DRUG ADMINISTRATION, HFS-681, 5001 CAMPUS DRIVE, COLLEGE PARK, MD 20740,
OR FAX IT TO 301-436-2804
FDA USE ONLY
Date Registration Form Received

Date Notification Sent to Facility

Public reporting burden for this collection of information is estimated to average between 1 and 12 hours per response, including the time for
reviewing Instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office An agency may not conduct or sponsor, and a person
of Chief Information Officer 1350 Piccard Drive, Rockville, MD 20850
is not required to respond to, a collection of
information unless it displays a currently valid OMB
control number.
FORM FDA 3537 (6/2016)

PAGE 6 OF 6