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For more assistance, please email glocentra@usa.com
 

Disclaimer: GLOCENTRA LLC accepts no liability or responsibility for the integrity of the information received or for the Food & Drug Administration's non-acceptance of registration information as provided by the submitter of the Data Inputs and the corresponding indications.

Consent Statement

Please complete the following statement:

I (full name) of (company name) hereby authorize GLOCENTRA LLC to register my company with the United States Food & Drug Administration for purposes of the Public Health Security and Bioterrorism Preparedness Act of 2002 (Bioterrorism Act).

Upon completion of this form, we agree to pay GLOCENTRA LLC a fee for this registration service and the related support
 
 
Contact Information
Phone Number E-Mail Address
 
Section 1: TYPE OF REGISTRATION
1a. Domestic Foreign
1b. Initial Registration Update of Registration Information
If update, provide the following:
Facility Registration Number
PIN
Check all that apply and further identify changes in the applicable sections. 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
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:
ZIP Code: Province / Territory:
Country: Phone Number (Include Area/Country Code):
Fax Number (Optional): E-Mail Address (Optional):
 
Section 3: PREFERRED MAILING ADDRESS INFORMATION (complete this section only if different from Section 2)
Name:
Address, Line 1:
Address, Line 2:
City: State:
ZIP Code: Province / Territory:
Country: Phone Number (Include Area/Country Code):
Fax Number (Optional): E-Mail Address (Optional):
 
Section 4: PARENT COMPANY NAME / ADDRESS INFORMATION (If applicable and if different from sections 2 & 3)
If information is the same as another section, check which section: SECTION 2 SECTION 3
Name of Parent Company:
Street Address, Line 1:
Street Address, Line 2:
City: State:
ZIP Code: Province / Territory:
Country: Phone Number (Include Area/Country Code):
Fax Number (Optional): E-Mail Address (Optional):
 
Section 5: FACILITY EMERGENCY CONTACT INFORMATION
Individual's Name (Optional):
Title (Optional): Emergency Contact Phone:
E-Mail Address (Optional):
 
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 U.S. Agent:
Title (Optional):
Address, Line 1:
Address, Line 2:
City: State: ZIP Code:
Phone Number (Include Area Code): E-Mail Address (Optional):
Fax Number (Optional):
 
Section 8: SEASONAL FACILITY DATES OF OPERATION
(GIVE THE APPROXIMATE DATES THAT YOUR FACILITY IS OPEN FOR BUSINESS, IF ITS OPERATIONS ARE ON A SEASONAL BASIS) (OPTIONAL)
Dates of Operation:
 
Section 9: 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 FOOD) (OPTIONAL)
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 PRIMARY HOLDERS) (OPTIONAL)
Ambient Storage (neither frozen nor refrigerated) Refrigerated Storage Frozen Storage
 
Section 11a: GENERAL PRODUCT CATEGORIES - FOOD FOR HUMAN CONSUMPTION
(TO BE COMPLETED BY ALL FOOD FACILITIES) (IF NONE OF THE MANDATORY CATEGORIES BELOW APPLY, SELECT BOX 37)
1. Alcoholic Beverages [21 CFR 170.3 (n) (2)] 21. Macaroni or Noodle Products [21 CFR 170.3 (n) (23)
2. Baby (Infant & Junior) Food Products Including Infant Formula (Optional Selection) 22. Meat, Meat Products and Poultry (FDA Regulated) [21 CFR 170.3 (n) (17), (18), (29), (34), (39), (40)]
3. Bakery Products, Dough Mixes, or Icings [21 CFR 170.3 (n) (1), (9)] 23. Milk, Butter, or Dried Milk Products [21 CFR 170.3 (n) (12), (30), (31)]
4. Beverage Bases [21 CFR 170.3 (n) (3), (16), (35)] 24. Multiple Food Dinners, Gravies, Sauces and Specialties [21 CFR 170.3 (n) (11), (14), (17), (18), (23), (24), (29), (34), (40)]
5. Candy Without Chocolate, Candy Specialties & Chewing Gum [21 CFR 170.3 (n) (6), (9), (25), (38)] 25. Nut and Edible Seed Products [21 CFR 170.3 (n) (26), (32)]
6. Cereal Preparations, Breakfast Foods, Quick Cooking / Instant Cereals [21 CFR 170.3 (n) (4)] 26. Prepared Salad Products [21 CFR 170.3 (n) (11), (17), (18), (22), (29), (34), (35)]
7. Cheese and Cheese Products [21 CFR 170.3 (n) (5)] 27. Shell Egg and Egg Products [21 CFR 170.3 (n) (11), (14)]
8. Chocolate and Cocoa Products [21 CFR 170.3 (n) (3), (9), (38), (43)] 28. Snack Food Items (Flour, Meal or Vegetable Base) [21 CFR 170.3 (n) (37)]
9. Coffee and Tea [21 CFR 170.3 (n) (3), (7)] 29. Spices, Flavors, and Salts [21 CFR 170.3 (n) (26)]
10. Color Additives For Foods [21 CFR 170.3 (o) (4)] 30. Soups [21 CFR 170.3 (n) (39), (40)]
11. Dietary Conventional Foods or Meal Replacements (including Medical Foods) [21 CFR 170.3 (n) (31)] 31. Soft Drinks and Waters [21 CFR 170.3 (n) (3), (35)]
12a. Dietary Supplements (Proteins, Amino Acids, Fats and Lipid Substances) [21 CFR 170.3 (0) (20)] 32. Vegetables and Vegetable Products [21 CFR 170.3 (n) (19), (36)]
12b. Dietary Supplements (Vitamins and Minerals) [21 CFR 170.3 (o) (20)] 33. Vegetable Oils (Includes Olive Oil) [21 CFR 170.3 (n) (12)]
12c. Dietary Supplements (Animal By-Products and Extracts (Optional Selection) 34. Vegetable Protein Products (Simulated Meats) [21 CFR 170.3 (n) (33)]
12d. Dietary Supplements (Herbals and Botanicals) (Optional Selection) 35. Whole Grains, Miller Grain Products (Flours), or Starch [21 CFR 170.3 (n) (1) (23)]
13. Dressings and Condiments [21 CFR 170.3 (n) (8), (12)] 36. Most / All Human Food Product Categories (Optional Selection)
14. Fishery / Seafood Products [21 CFR 170.3 (n) (13), (15), (39), (40)] 37. None of the Above Mandatory Categories
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), (4), (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)]
 
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 & 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 OF INFORMATION
Name of Entity 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 SECTION 3 SECTION 4 SECTION 7
Street Address, Line 1:
Street Address, Line 2:
City: State:
ZIP Code: Province / Territory:
Country: Phone Number (Include Area/Country Code):
Fax Number (Optional): E-Mail Address (Optional):

 
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 the 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 as materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.
NAME OF SUBMITTER:
SELECT ONE
A) OWNER, OPERATOR OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED)
B) INDIVIDUAL AUTHORIZED TO SUBMIT THE REGISTRATION (FILL IN BELOW)
IF YOU SELECTED OPTION 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)
Street Address, Line 1:
Street Address, Line 2:
City: State:
ZIP Code: Province / Territory:
Country: Phone Number (Include Area/Country Code):
Fax Number (Optional): E-Mail Address (Optional):
THANK YOU FOR YOUR CONSIDERATION

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