|
The
following Form are for information only, so you can view the
data required by the FDA. If you would like to Officially
Register, click on any of the "register buttons"
located on top, on the right side and bottom of the page or
click here.
| Date:
(MONTH/DAY/YEAR) |
Section
1 - TYPE OF REGISTRATION |
|
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: |
| CITY
|
STATE:
|
| ZIP
CODE (POSTAL CODE): |
PROVINCE/TERRITORY:
|
| COUNTRY:
|
PHONE
NUMBER(if a foreign facility, include Area & Country
Codes): |
| FAX
NUMBER (if available; if a foreign facility, include Area
& Country Codes): |
E-MAIL
ADDRESS (if available): |
Section
3 - OPTIONAL: PREFERRED MAILING ADDRESS INFORMATION
(only complete this section if different
from Section 2, Facility Name/Address Information) |
| NAME:
|
| ADDRESS:
|
| CITY:
|
STATE:
|
| ZIP
CODE (POSTAL CODE): |
PROVINCE/TERRITORY:
|
| COUNTRY:
|
PHONE
NUMBER (if a foreign facility, include Area & Country
Codes): |
| FAX
NUMBER (if a foreign facility, include Area & Country
Codes): |
E-MAIL
ADDRESS: |
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 - Facility Address Information or |
| Section
3 - Preferred Mailing Address Information |
|
| NAME
OF PARENT COMPANY: |
| STREET
ADDRESS OF PARENT COMPANY: |
| CITY:
|
STATE:
|
| ZIP
CODE (POSTAL CODE): |
PROVINCE/TERRITORY
|
| COUNTRY:
|
PHONE
NUMBER (if a foreign facility, include Area & Country
Codes): |
| FAX
NUMBER (if a foreign facility, include Area & Country
Codes): |
E-MAIL
ADDRESS (If available): |
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'S
NAME: |
| TITLE:
|
OFFICE
PHONE(If a foreign facility, include Area & Country
Codes): |
| HOME
PHONE (if a foreign facility, include Area & Country
Codes): |
CELL
PHONE (if a foreign facility, include Area & Country
Codes):
|
| E-MAIL
ADDRESS(If available): |
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.) |
| NAME
OF UNITED STATES AGENT: This
Section will be filled in by Global Trading Hub |
| TITLE:
|
| ADDRESS:
|
| CITY:
|
STATE:
|
| ZIP
CODE: |
COUNTRY:
|
| PHONE
NUMBER (include Area code): |
| FAX
NUMBER (if available; indude Area Code): |
| E-MAIL
ADDRESS (if available): |
Section
8 - OPTIONAL: SEASONAL FACILITY DATES OF OPERATION
(GIVE THE APPROXIMATE DATES THAT YOUR FACILITY IS OPEN
FOR BUSINESS, IF ITS OPERATIONS
ARE ON A SEASONAL BASIS) |
| DATES
OF OPERATION: |
Section
9 - OPTIONAL: ESTABLISHMENT TYPES
(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,
induding 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 - OPTIONAL: IF YOUR FACILITY IS SOLELY A WAREHOUSE
/ HOLDING FACILITY,
COMPLETE THIS SECTION; ALL OTHER FACILITIES, COMPLETE
SECTION 11 (human or
animal product categories) INSTEAD OF THIS SECTION. |
|
Ambient Storage ( including heated storage) |
Refrigerated Storage |
Frozen Storage |
|
Section
11a
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) (l0)] |
| |
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 /
SPECIALITIES & 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) (ll), (14)] |
| |
11.
DIETARY CONVENTIONAL FOODS OR MEAL
REPLACEMENTS (indudes Medical Foods)
[21 CFR 170.3 (n ) (31)] |
|
28.
SNACK FOOD ITEMS (FLOUR, MEAL OR VEGETABLE BASE)
[21 CFR 170.3 (n) (37)] |
| |
12. DIETARY SUPPLEMENTS
|
|
29.
SPICES, FLAVORS, AND SALTS
[21 CFR 170.3 (n) (26)] |
| |
Proteins,
Amino Acids, Fats and Lipid Substances
[21 CFR 170.3 (0) (20)] |
|
30.
SOUPS
[21 CFR 170.3 (n) (39). (40)] |
| |
Vitamins and Minerals [21 CFR 170.3 (0) (20)] |
|
31.
SOFT DRINKS AND WATERS
[21 CFR 170.3 (n) (3), (35)] |
| |
Animal
By-Products and Extracts (Optional
Selection) |
|
32.
VEGETABLES AND VEGETABLE PRODUCTS
[21 CFR 170.3 (n) (19). (36)] |
| |
Herbals
and Botanicals (Optional Selection) |
|
33.
VEGETABLE OILS (INCLUDES OLIVE OIL)
[21 CFR 170.3 (n) (12)] |
| |
13.
DRESSINGS AND CONDIMENTS
[21 CFR 170.3 (n) (8). (12)] |
|
34.
VEGETABLE PROTEIN PRODUCTS (SIMULATED MEATS)
[ 21 CFR 170.3 (n) (33)] |
| |
14.
FISHERY/SEAFOOD PRODUCTS
[21 CFR 170.3 (n) (13). (15). (39), (40)] |
|
35.
WHOLE GRAINS, MILLER GRAIN PRODUCTS (FLOURS), OR
STARCH
[21 CFR 170.3 (n) (l), (23)] |
| |
15.
FOOD ADDITIVES, GENERALLY RECOGNIZED AS SAFE (GRAS)
INGREDIENTS, OR OTHER INdREDlENTS 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) |
|
36.
MOST/ALL HUMAN FOOD PRODUCT CATEGORIES(Optional
Selection) |
| |
16.
FOOD SWEETENERS (NUTRITIVE)
[21 CFR 170.3 (n) (9), (41), 21 CFR 170.3 (0)(21)] |
|
37.
NONE OF THE ABOVE MANDATORY CATEGORIES |
| |
17.
FRUITS AND FRUIT PRODUCTS
[21 CFR 170.3 (n) (16), (27), (28). (35). (43)]
|
|
|
|
Section
11b - OPTIONAL GENERAL PRODUCT CATEGORIES - FOOD FOR
ANIMAL
CONSUMPTION |
| |
1.
GRAIN PRODUCTS (E.G., BARLEY, GRAIN SORGHUMS, MAIZE,
OAT, RICE. RYE AND
WHEAT) |
|
18.
NON-PROTEIN NITROGEN PRODUCTS |
| |
2.
OILSEED PRODUCTS (E.G., COTTONSEED. SOYBEANS, OTHER
OIL SEEDS) |
|
19.
PEANUT PRODUCTS |
| |
3.
ALFALFA AND LESPEDEZA PRODUCTS |
|
20.
RECYCLED ANIMAL WASTE PRODUCTS |
| |
4.
AMINO ACIDS |
|
21.
SCREENINGS |
| |
5.
ANIMAL-DERIVED PRODUCTS |
|
22.
VITAMINS |
| |
6.
BREWER PRODUCTS |
|
23.
YEAST PRODUCTS |
| |
7.
CHEMICAL PRESERVATIVES |
|
24.
MIXED FEED (POULTRY, LIVESTOCK. AND EQUINE) |
| |
8.
CITRUS PRODUCTS |
|
25.
PET FOOD |
| |
9.
DISTILLERY PRODUCTS |
|
26.
MOST/ALL ANIMAL FOOD PRODUCT CATEGORIES |
| |
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 |
|
|
|
| |
| Section
12 |
| |
*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 INFORMATION IS THE SAME AS ANOTHER
SECTION OF THE FORM, CHECK WHICH SECTION:
| |
|
Section 2 - Facility Address Information |
|
Section 3 - Preferred Mailing Address Information
|
|
Section 4 - Parent Company Address Information
|
| |
|
Section 7 - US Agent Address Information |
|
|
|
STREET ADDRESS |
|
CITY |
|
COUNTRY: |
| STATE/PROVINCE/TERRITORY
|
| ZIP
CODE (POSTAL CODE) |
| Numbers
only. No spaces, dashes or parentheses. Country
Code not required for US phone numbers. |
| PHONE
|
| FAX
NUMBER |
|
|
| E-MAIL
ADDRESS |
| |
|
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 ture 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, ficticious, or fraudulent
statement to the U.S. Government is subject to
criminal penalties. |
|
PRINT
NAME OF PERSON SUBMITTING THE REGISTRATION FORM:
| CHECK
ONE BOX |
|
A.OWNER, OPERATOR, OR AGENT IN CHARGE (STOP
HERE, FORM IS COMPLETED) |
|
B.INDIVIDUAL AUTHORIZED TO SUBMIT THE REGISTRATION
(FILL IN ADDRESS 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) |
These
fields are required only if the section applies
ADDRESS INFORMATION FOR THE AUTHORIZING INDIVIDUAL:  |
| |
| AUTHORIZING
INDIVIDUAL STREET ADDRESS |
| CITY
|
| COUNTRY
|
| STATE/PROVINCE/TERRITORY
|
| ZIP
CODE (POSTAL CODE) |
| PHONE
NUMBER |
| FAX
NUMBER |
| E-MAIL
ADDRESS |
|
If
you have been referred by a person or company, please
enter the Name and Associate Number here:
|
Name: |
| Associate Number |
|