Free FORM FDA 3537 - Federal

Form Approval: OMB No. 0910-0502; Expiration date: 5/31/2010; See OMB Statement on page 6.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

FDA USE ONLY

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. 1b. DOMESTIC REGISTRATION INITIAL REGISTRATION
If update, provide the Facility Registration Number and PIN Facility Registration Number

FOREIGN REGISTRATION UPDATE OF REGISTRATION INFORMATION
PIN

Check all that apply and further identify changes in the applicable sections Facility Name Change Facility Address Change (See instructions) Preferred Mailing Address Change Parent Company Change Emergency Contact Change Trade Name Change If "Yes", provide the following information, if known. Previous owner's name

United States Agent Change - Foreign facilities only Seasonal Facility Dates of Operation Change Type of Activity Change Type of Storage Change Human Food Product Category Change Animal Food Product Category Change Operator or Agent in Charge Change

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

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 Province/Territory (If applicable) Country FAX Number (Optional; Include Area/Country Code) State (If applicable; if not, skip to Province/Territory) ZIP or Postal Code Phone Number (Include Area/Country Code) E-Mail Address (Optional)

FORM FDA 3537 (11/08)

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PSC Graphics (301) 443-1090

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 Province/Territory (If applicable) Country FAX Number (Optional; Include Area/Country Code) State (If applicable; if not, skip to Province/Territory) ZIP or Postal Code Phone Number (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:
Name of Parent Company Street Address of Parent Company, Line 1 Street Address of Parent Company, Line 2 City Province/Territory (If applicable) Country FAX Number (Optional; Include Area/Country Code) State (If applicable; if not, skip to Province/Territory) ZIP or Postal Code Phone Number (Include Area/Country Code) E-Mail Address (Optional)

Section 2

Section 3

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) Emergency Contact Phone (Include Area/Country Code)

FORM FDA 3537 (11/08)

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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 U.S. Agent Phone Number (Include Area Code) FAX Number (Optional; Include Area Code) State ZIP Code Emergency Contact Phone Number (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 Interstate Conveyance Caterer / Catering Point Molluscan Shellfish Establishment Commissary Contract Sterilizer Labeler / Relabeler Manufacturer / Processor Repacker / Packer Salvage Operator (Reconditioner) Animal food manufacturer / processor / holder

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

FORM FDA 3537 (11/08)

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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)] 2. BABY (INFANT AND JUNIOR) FOOD PRODUCTS Including Infant Formula (Optional Selection) 3. BAKERY PRODUCTS, DOUGH MIXES, OR ICINGS [21 CFR 170.3 (n) (1), (9)] 4. BEVERAGE BASES [21 CFR 170.3 (n) (3), (16), (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 PRODUCTS [21 CFR 170.3 (n) (5)] 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 SUPPLEMENTS Proteins, Amino Acids, Fats and Lipid Substances [21 CFR 170.3 (o) (20)] Vitamins and Minerals [21 CFR 170.3 (o) (20)] Animal By-Products and Extracts (Optional Selection) Herbals and Botanicals (Optional Selection) 13. DRESSING AND CONDIMENTS [21 CFR 170.3 (n) (8), (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)] 18. GELATIN, RENNET, PUDDING MIXES, OR PIE FILLINGS [21 CFR 170.3 (n) (22)] 19. ICE CREAM AND RELATED PRODUCTS [21 CFR 170.3 (n) (20), (21)] 20. IMITATION MILK PRODUCTS [21 CFR 170.3 (n) (10)] 21. MACARONI OR NOODLE PRODUCTS [21 CFR 170.3 (n) (23)] 22. MEAT, MEAT PRODUCTS AND POULTRY (FDA REGULATED) [21 CFR 170.3 (n) (17), (18), (29), (34), (39), (40)] 23. MILK, BUTTER, OR DRIED MILK PRODUCTS [21 CFR 170.3 (n) (12), (30), (31)] 24. MULTIPLE FOOD DINNERS, GRAVIES, SAUCES AND SPECIALTIES [21 CFR 170.3 (n) (11) (14), (17), (18), (23), (24), (29), (34), (40)] 25. NUT AND EDIBLE SEED PRODUCTS [21 CFR 170.3 (n) (26), (32)] 26. PREPARED SALAD PRODUCTS [21 CFR 170.3 (n) (11), (17), (18), (22), (29), (34), (35)] 27. SHELL EGG AND EGG PRODUCTS [21 CFR 170.3 (n) (11), (14)] 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)] 30. SOUPS [21 CFR 170.3 (n) (39), (40)] 31. SOFT DRINKS AND WATERS [21 CFR 170.3 (n) (3), (35)] 32. VEGETABLE AND VEGETABLE PRODUCTS [21 CFR 170.3 (n) (19), (36)] 33. VEGETABLE OILS (INCLUDES OLIVE OIL) [21 CFR 170.3 (n) (12)] 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

FORM FDA 3537 (11/08)

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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) 2. OILSEED PRODUCTS (E.G., COTTONSEED, SOYBEANS, OTHER OIL SEEDS) 3. ALFALFA AND LESPEDEZA PRODUCT 4. AMINO ACID 5. ANIMAL-DERIVED PRODUCTS 6. BREWER PRODUCTS 7. CHEMICAL PRESERVATIVES 8. CITRUS PRODUCTS 9. DISTILLERY PRODUCTS 10. ENZYMES 11. FATS AND OILS 12. FERMENTATION PRODUCTS 13. MARINE PRODUCTS 14. MILK PRODUCTS 15. MINERALS 16. MISCELLANEOUS AND SPECIAL PURPOSE PRODUCTS 17. MOLASSES 18. NON-PROTEIN NITROGEN PRODUCTS 19. PEANUT PRODUCTS 20. RECYCLED ANIMAL WASTE PRODUCTS 21. SCREENINGS 22. VITAMINS 23. YEAST PRODUCTS 24. MIXED FEED (POULTRY, LIVESTOCK, AND EQUINE) 25. PET FOOD 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 Street Address, Line 1 Street Address, Line 2 City Province/Territory (If applicable) Country FAX Number (Optional; Include Area/Country Code) State (If applicable; if not, skip to Province/Territory) ZIP or Postal Code Phone Number (Include Area/Country Code) E-Mail Address (Optional) SECTION 3 SECTION 4 SECTION 7

FORM FDA 3537 (11/08)

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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 Province/Territory (If applicable) Country FAX Number (Optional; Include Area/Country Code) State (If applicable; if not, skip to Province/Territory) ZIP or Postal Code Phone Number (Include Area/Country Code) E-Mail Address (Optional)

MAIL COMPLETED FORM FDA 3537 TO U.S. FOOD AND DRUG ADMINISTRATION, HFS-681, 5600 FISHERS LANE, ROCKVILLE, MD 20857, 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 (HFA-710) 5600 Fishers Lane Rockville, MD 20857 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.

FORM FDA 3537 (11/08)

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