FDA Food Facility Registration Form

Who needs FDA food facility registration?

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

- Step 1 of 14

Section 1 - Type of Registration

Foreign or Domestic Registration *

Domestic
Foreign

Registration Type *

Initial Registration
Update Registration
Renew Registration

Facility Registration Number *

PIN *

Further identify changes in the applicable sections (Check all that apply) *

Facility Name Change
Facility Address Change
Preferred Mailing Address Change
Parent Company Change
Emergency Contact Change
Trade Name Change
United States Agent Change - Foreign facilities only
Seasonal Facility Dates of Operation Change
Type of Activity Change
Human Food Product Category Change
Animal Food Product Category Change
Operator or Agent in Charge Change

Are you the owner of a recently registered facility? *

Previous owner's name *

Previous owner's registration number *

Section 2 - Facility Name/Address

Facility Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Email *

Phone *

FAX

DUNS Number

Section 3 - Preferred Mailing Address

Is the preferred mailing address the same as in Section 2? *

Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Email *

Phone *

FAX

Section 4 - Parent Company Name/Address

Is the parent company address the same as in Section 2 or 3?

Select which section

Name of Parent Company *

Address *

Address Line 1

Address Line 2

City

State

Zip Code

Email *

Phone *

FAX

Section 5 - Facility Emergency Contact

Name *

Job Title

Email *

Emergency Contact Phone *

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”) *

Alternate Trade Name #1 *

Alternate Trade Name #2

Alternate Trade Name #3

Alternate 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. ARx Global Services will be appointed as your agent if requested.

Would you like ARx Global Services to be your agent? *

Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Email *

Phone *

Section 8 - Seasonal Facility Dates of Operation (Optional)

Dates of Operation (Optional; mm/dd/yyyy)

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

1. ALCOHOLIC BEVERAGES [21 CFR 170.3 (n) (2)] *

Types of Activity Conducted at the facility (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply)

7. CHEESE AND CHEESE PRODUCT CATEGORIES [21 CFR 170.3 (n) (5)] *

Types of Activity Conducted at the facility (Select all that apply)

a. Soft, Ripened Cheese (Select all that apply)

b. Semi-Soft Cheese (Select all that apply)

c. Hard Cheese (Select all that apply)

d. Other Cheeses and Cheese Products (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

12. DIETARY SUPPLEMENT CATEGORIES *

Types of Activity Conducted at the facility (Select all that apply) *

a. Proteins, Amino Acids, Fats and Lipid Substances [21 CFR 170.3 (o) (20)] (Select all that apply)

b. Vitamins and Minerals [21 CFR 170.3 (o) (20)] (Select all that apply)

c. Animal By-Products and Extracts (Select all that apply)

d. Herbals and Botanicals (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply) *

14. FISHERY/SEAFOOD PRODUCT CATEGORIES [21 CFR 170.3 (n) (13), (15), (39), (40)] *

Types of Activity Conducted at the facility (Select all that apply) *

a. Fin Fish, Whole or Filet (Select all that apply)

b. Molluscan Shellfish (Select all that apply)

c. Other Shellfish (Select all that apply)

d. Ready to Eat (RTE) Fishery Products (Select all that apply)

e. Processed and Other Fishery Products (Select all that apply)

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)] *

Types of Activity Conducted at the facility (Select all that apply) *

16. FOOD SWEETENERS (NUTRITIVE) [21 CFR 170.3 (n) (9) (41), 21 CFR 170.3 (o) (21)] *

Types of Activity Conducted at the facility (Select all that apply) *

17. FRUIT AND FRUIT PRODUCTS [21 CFR 170.3 (n) (16), (27), (28), (35), (43)] *

Types of Activity Conducted at the facility (Select all that apply) *

a. Fresh Cut Produce (Select all that apply)

b. Raw Agricultural Commodities (Select all that apply)

c. Other Fruit and Fruit Products (Select all that apply)

18. FRUIT OR VEGETABLE JUICE, PULP OR CONCENTRATE PRODUCTS [21 CFR 170.3 (n) (3), (16), (35)] *

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

26. NUTS AND EDIBLE SEED PRODUCT CATEGORIES [21 CFR 170.3 (n) (26), (32)] *

Types of Activity Conducted at the facility (Select all that apply) *

a. Nut and Nut Products (Select all that apply)

b. Edible Seed and Edible Seed Products (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply) *

28. SHELL EGG AND EGG PRODUCT CATEGORIES [21 CFR 170.3 (n) (11), (14)] *

Types of Activity Conducted at the facility (Select all that apply) *

a. Chicken Egg and Egg Products (Select all that apply)

b. Other Eggs and Egg Products (Select all that apply)

29. SNACK FOOD ITEMS (FLOUR, MEAL OR VEGETABLE BASE) [21 CFR 170.3 (n) (37)] *

Types of Activity Conducted at the facility (Select all that apply) *

30. SPICES, FLAVORS, AND SALTS [21 CFR 170.3 (n) (26)] *

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

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

Types of Activity Conducted at the facility (Select all that apply) *

33. VEGETABLE AND VEGETABLE PRODUCT CATEGORIES [21 CFR 170.3 (n) (19), (36)] *

Types of Activity Conducted at the facility (Select all that apply) *

a. Fresh Cut Products (Select all that apply)

b. Raw Agricultural Commodities (Select all that apply)

c. Other Vegetable and Vegetable Products (Select all that apply)

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

Types of Activity Conducted at the facility (Select all that apply) *

35. VEGETABLE PROTEIN PRODUCTS (SIMULATED MEATS) [21 CFR 170.3 (n) (33)] *

Types of Activity Conducted at the facility (Select all that apply) (copy) *

36. WHOLE GRAINS, MILLER GRAIN PRODUCTS (FLOURS), OR STARCH [21 CFR 170.3 (n) (1), (23)] *

Types of Activity Conducted at the facility (Select all that apply) (copy) (copy) *

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). *

Types of Activity Conducted at the facility (Select all that apply) *

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

1. GRAIN OR GRAIN PRODUCTS (I.E., BARLEY, GRAIN SORGHUMS, MAIZE, OAT, RICE, RYE, WHEAT, OTHER GRAINS OR GRAIN PRODUCTS) *