Form FDA Form 3537 FDA Form 3537 Food Facility Registration

Form Approval: OMB No. 0910-0502; Expiration date: 8/31/2013; 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

If update, provide the Facility
Registration Number and PIN

Facility Registration Number

Check all that apply and further identify changes in the
applicable sections

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

Type of Storage Change

Parent Company Change

Human Food Product Category Change

Emergency Contact Change

Animal Food Product Category Change

Trade Name Change

Operator or Agent in Charge Change

1c. ARE YOU THE NEW OWNER OF A PREVIOUSLY REGISTERED FACILITY?

Yes

No

If "Yes", provide the following information, if known.
Previous owner's name

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)

FORM FDA 3537 (8/11)

E-Mail Address (Optional)

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PSC Publishing Services (301) 443-6740

EF

Section 3 - PREFERRED MAILING ADDRESS INFORMATION - Complete this section only if different from Section 2,
Facility Name/Address Information. (OPTIONAL)
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 (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
Optional for foreign facilities; FDA will use your U.S. agent as your emergency contact unless you choose to designate a
different contact here.
Individual Name (Optional)
Title (Optional)
E-Mail Address (Optional)

FORM FDA 3537 8/11)

Emergency Contact Phone (Include Area/Country Code)

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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

ZIP Code

State

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

Emergency Contact Phone Number (Include Area Code)

FAX Number (Optional; Include Area Code)

E-Mail Address (Optional)

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

Section 9 - TYPE OF ACTIVITY CONDUCTED AT THE FACILITY
Optional - Check all types of operations that are performed at this facility regarding the manufacturing/processing, packing
or holding of food.
Warehouse / Holding Facility (e.g., storage facilities, including storage tanks, grain elevators)
Acidified / Low Acid Food Processor

Labeler / Relabeler

Interstate Conveyance Caterer / Catering Point

Manufacturer / Processor

Molluscan Shellfish Establishment

Repacker / Packer

Commissary

Salvage Operator (Reconditioner)

Contract Sterilizer

Animal food manufacturer / processor / holder

Section 10 - TYPE OF STORAGE (FOR FACILITIES THAT ARE PRIMARILY HOLDERS) (OPTIONAL)
Ambient Storage (neither frozen nor refrigerated)

FORM FDA 3537 (8/11)

Refrigerated Storage

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Frozen Storage

Section 11a - GENERAL PRODUCT CATEGORIES - FOOD FOR HUMAN CONSUMPTION
To be completed by all food facilities. Please see instructions for further examples.
IF NONE OF THE MANDATORY CATEGORIES BELOW APPLY, SELECT BOX 37.
1. ALCOHOLIC BEVERAGES
[21 CFR 170.3 (n) (2)]

18. GELATIN, RENNET, PUDDING MIXES, OR PIE FILLINGS
[21 CFR 170.3 (n) (22)]

2. BABY (INFANT AND JUNIOR) FOOD PRODUCTS
Including Infant Formula (Optional Selection)

19. ICE CREAM AND RELATED PRODUCTS
[21 CFR 170.3 (n) (20), (21)]

3. BAKERY PRODUCTS, DOUGH MIXES, OR ICINGS
[21 CFR 170.3 (n) (1), (9)]

20. IMITATION MILK PRODUCTS
[21 CFR 170.3 (n) (10)]

4. BEVERAGE BASES
[21 CFR 170.3 (n) (3), (16), (35)]

21. MACARONI OR NOODLE PRODUCTS
[21 CFR 170.3 (n) (23)]

5. CANDY WITHOUT CHOCOLATE, CANDY SPECIALTIES
AND CHEWING GUM
[21 CFR 170.3 (n) (6), (9), (25), (38)]

22. MEAT, MEAT PRODUCTS AND POULTRY
(FDA REGULATED)
[21 CFR 170.3 (n) (17), (18), (29), (34), (39), (40)]

6. CEREAL PREPARATIONS, BREAKFAST FOODS, QUICK
COOKING / INSTANT CEREALS
[21 CFR 170.3 (n) (4)]

23. MILK, BUTTER, OR DRIED MILK PRODUCTS
[21 CFR 170.3 (n) (12), (30), (31)]

7. CHEESE AND CHEESE PRODUCTS
[21 CFR 170.3 (n) (5)]

24. MULTIPLE FOOD DINNERS, GRAVIES, SAUCES AND
SPECIALTIES [21 CFR 170.3 (n) (11) (14), (17), (18), (23),
(24), (29), (34), (40)]

8. CHOCOLATE AND COCOA PRODUCTS
[21 CFR 170.3 (n) (3), (9), (38), (43)]

25. NUT AND EDIBLE SEED PRODUCTS
[21 CFR 170.3 (n) (26), (32)]

9. COFFEE AND TEA
[21 CFR 170.3 (n) (3), (7)]

26. PREPARED SALAD PRODUCTS
[21 CFR 170.3 (n) (11), (17), (18), (22), (29), (34), (35)]

10. COLOR ADDITIVES FOR FOODS
[21 CFR 170.3 (o) (4)]

27. SHELL EGG AND EGG PRODUCTS
[21 CFR 170.3 (n) (11), (14)]

11. DIETARY CONVENTIONAL FOODS OR MEAL
REPLACEMENTS (Includes Medical Foods)
[21 CFR 170.3 (n) (31)]

28. SNACK FOOD ITEMS (FLOUR, MEAL OR VEGETABLE
BASE) [21 CFR 170.3 (n) (37)]
29. SPICES, FLAVORS, AND SALTS
[21 CFR 170.3 (n) (26)]

12. DIETARY SUPPLEMENTS
Proteins, Amino Acids, Fats and Lipid Substances
[21 CFR 170.3 (o) (20)]

30. SOUPS
[21 CFR 170.3 (n) (39), (40)]

Vitamins and Minerals [21 CFR 170.3 (o) (20)]

31. SOFT DRINKS AND WATERS
[21 CFR 170.3 (n) (3), (35)]

Animal By-Products and Extracts (Optional Selection)
Herbals and Botanicals (Optional Selection)

32. VEGETABLE AND VEGETABLE PRODUCTS
[21 CFR 170.3 (n) (19), (36)]

13. DRESSING AND CONDIMENTS
[21 CFR 170.3 (n) (8), (12)]

33. VEGETABLE OILS (INCLUDES OLIVE OIL)
[21 CFR 170.3 (n) (12)]

14. FISHER / SEAFOOD PRODUCTS
[21 CFR 170.3 (n) (13), (15), (39), (40)]
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. FRUITS AND FRUIT PRODUCTS
[21 CFR 170.3 (n) (16), (27), (28), (35), (43)]

FORM FDA 3537 (8/11)

34. VEGETABLE PROTEIN PRODUCTS (SIMULATED MEATS)
[21 CFR 170.3 (n) (33)]
35. WHOLE GRAINS, MILLER GRAIN PRODUCTS (FLOURS),
OR STARCH
[21 CFR 170.3 (n) (1), (23)]

36. MOST / ALL HUMAN FOOD PRODUCT CATEGORIES
(Optional Selection)

37. NONE OF THE ABOVE MANDATORY CATEGORIES

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Section 11b - GENERAL PRODUCT CATEGORIES - FOOD FOR ANIMAL CONSUMPTION (OPTIONAL)
1. GRAIN PRODUCTS (E.G., BARLEY, GRAIN SORGHUMS,
MAIZE, OAT, RICE, RYE AND WHEAT)

14. MILK PRODUCTS

2. OILSEED PRODUCTS (E.G., COTTONSEED, SOYBEANS,
OTHER OIL SEEDS)

15. MINERALS

3. ALFALFA AND LESPEDEZA PRODUCT

16. MISCELLANEOUS AND SPECIAL PURPOSE PRODUCTS

4. AMINO ACID

17. MOLASSES

5. ANIMAL-DERIVED PRODUCTS

18. NON-PROTEIN NITROGEN PRODUCTS

6. BREWER PRODUCTS

19. PEANUT PRODUCTS

7. CHEMICAL PRESERVATIVES

20. RECYCLED ANIMAL WASTE PRODUCTS

8. CITRUS PRODUCTS

21. SCREENINGS

9. DISTILLERY PRODUCTS

22. VITAMINS

10. ENZYMES

23. YEAST PRODUCTS

11. FATS AND OILS

24. MIXED FEED (POULTRY, LIVESTOCK, AND EQUINE)

12. FERMENTATION PRODUCTS

25. PET FOOD

13. MARINE PRODUCTS

26. MOST / ALL ANIMAL FOOD PRODUCT CATEGORIES

Section 12 - 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 (8/11)

E-Mail Address (Optional)

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Section 13 - 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 authorizing an 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. OWNER, OPERATOR OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED)
B. INDIVIDUAL AUTHORIZED TO SUBMIT THE REGISTRATION (FILL IN BELOW)
If you checked Box B above, indicate who authorized you to submit the registration.
OWNER, OPERATOR OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED)
- NAME OF INDIVIDUAL WHO AUTHORIZED
REGISTRATION ON BEHALF OF OWNER, OPERATOR, OR AGENT IN CHARGE (FILL IN ADDRESS BELOW)
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 (Optional)

MAIL COMPLETED FORM FDA 3537 TO U.S. FOOD AND DRUG ADMINISTRATION, FOOD FACILITY REGISTRATION,
5100 PAINT BRANCH PARKWAY, HFS-681, COLLEGE PARK, MD 20993 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 of Chief Information Officer
1350 Piccard Drive, Room 400
Rockville, MD 20850

FORM FDA 3537 (8/11)

An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of
information unless it displays a currently valid OMB
control number.

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