The FDA Registration form

FDA Registration Form 3537

PLEASE FILL-IN ALL FIELDS MARKED WITH *

SECTION 1:

TYPE OF REGISTRATION

Type of Registration:

Is this your initial registration: Yes / No

FDA Number:

If No., please state your present FDA Number:

SECTION 2:

FACILITY NAME / ADDRESS INFORMATION

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Facility Name:

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Facility Address: Line 1

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Facility Address: Line 2

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City:

State:

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Postal Code:

Province/Territory:

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Country:

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Phone No.:

Fax No.:

e-Mail address:

SECTION 3: (Optional)

PREFERRED MAILING ADDRESS INFORMATION

Name:

Address: Line 1

Address: Line 2

City:

State:

Postal Code:

Province/Territory:

Country:

Phone No.:

Fax No.:

e-Mail address:

SECTION 4:(If applicable)

PARENT COMPANY NAME / ADDRESS (If applicable and ONLY if different

from sections 2 and 3 above)

Name of Parent Company

of your Facility:

Parent Address: Line 1

Parent Address: Line 2

Parent City:

State:

Parent Postal Code:

Parent Province/Territory:

Parent Country:

Parent Phone No.:

Parent Fax No.:

Parent e-Mail address:

SECTION 5:

FACILITY EMERGENCY CONTACT INFORMATI0N

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State full name of

emergency contact person:

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What is the title of the

emergency contact person:

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Office Phone No.:

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Cell Phone No.:

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e-Mail address:

SECTION 6:

TRADE NAMES (If this facility uses trade names other than that listed in

Section 2 above, list them below) i.e. "doing business as", "facility known as"

Alternate Trade Name #1:

Alternate Trade Name #2:

Alternate Trade Name #3:

Alternate Trade Name #4:

SECTION 7:

UNITED STATES AGENT

All facilities physically located outside the United States must appoint a United States agent located in the united States as a point of contact with U.S. Food and Drug Administration.

LALANDIA, INC., will be the appointed United States agent for the facility.

U.S. Agent Agreement:

(En español)

The following is an agreement between Lalandia, Inc., a corporation registered in Florida, U.S.A. (to be referred to as "Agent") and the below foreign Food Facility or Manufacture, (to be referred to as "Company"). Agent offers services to food companies pursuant to US FDA regulations at 21 CFR Part 1, Subpart H, (the "Regulations"), requiring appointment of a resident US agent. Company wishes to engage the professional services of Agent for the purpose of maintaining uninterrupted compliance with the Regulations. Therefore, in consideration of the mutual promises herein contained, and other good and valuable consideration, the parties agree as follows:
1. TERM. This Agreement shall become effective on submitting this form, as per the automatic date stamp in the Confirmation Page hereof, (the "Effective Date") and shall continue in full force and effect until terminated by either party upon at least 90 days’ prior written notice. 
2. ENGAGEMENT FEE. Company shall pay Agent a fee to act as its US Agent, starting on the Effective Date. The fee, for each facility, is $350 for the first calendar year in which is was requested and $250 for each subsequent year. The first year’s fee of $350 is due and payable upon signing this Agreement. FDA requires each separate facility to submit a separate registration. "Facility" is defined at 21 CFR § 1.227. If Company has more than one facility. Fees shall be paid in US currency, by Credit Card or Company check or by electronic transfer to Agent’s bank. Agent is responsible for submitting electronic invoices for Agent services rendered in the second and following years. Invoices are due and payable upon receipt. Invoices not paid within 30 days of the date rendered will be subject to interest charged at the rate of 1.25 percent per month. During the course of registration, if Agent determines that registration is not necessary for any given facility under available FDA rules, Agent shall prepare a letter to Company explaining that registration is not required, and setting forth the basis for this legal determination. Upon preparing this letter, Agent shall promptly refund 25% of all fees paid for the facility at issue, for the then-current year. 
3. DUTIES OF AGENT

A. Agent shall at all times during the term of this Agreement:
i.	Maintain a place of business within the US, in the manner required by the Regulations, including a telephone, answering service, email and fax. 
ii.	Assist Company in properly filing FDA Form 3537, the Food Facility Registration form (the "Form"). This will designate Agent as Company’s United States Agent, in compliance with the Regulations. 
iii.	Accept all calls, email and written communications ("Information") from FDA regarding the Company and/or its products and accurately convey the same to Company, within 2 business days, excluding Saturday, Sunday and US holidays. Agent will convey the Information to Company by phone, email, mail or FedEx as Agent deems appropriate. There is no extra charge for conveying Information to Company except FedEx will be charged to Company at Agent’s actual cost. Agent reserves the right to charge a reasonable fee if it becomes necessary to convey information to Company more than 50 times per year. 
iv.	Update the Form within 10 days of receiving updated information from the Company or as otherwise agreed. There is no extra charge for submitting updates except Agent reserves the right to charge $100 per update for submitting more than two updates per year. Agent shall be allowed an extra 5 days to update the form if Company provides information in a language other than English. 
B. Absent a separate agreement to the contrary, Agent shall not:
i.	Provide any legal, business or other advice outside the scope of the Regulations. 
4. DUTIES OF COMPANY

A. Within 3 days of signing this Agreement, Company shall provide Agent with: 
i.	Substantially all of the information required to be submitted on the Form. 
ii.	Information provided by the Company must be legible and intelligible. Company may provide Information to Agent in a language other than English but Agent reserves the right to charge the actual cost for professional translation plus a 25 percent translation fee. (Minimum fee of $100)
B. Company shall at all times during this Agreement: 
i.	Respond to any communication under 3.A.iii. above within 3 days. 
ii.	Ensure that information provided to Agent is truthful and accurate. 
5. CONFIDENTIALITY. Agent shall maintain Company’s information in a confidential manner consistent with Agent’s responsibilities as an Agent

6. TERMINATION. This Agreement may be terminated without cause by either party upon 90 days prior written notice of the intent to do so. If the Company terminates this Agreement under this section it will not be entitled to a refund of fees paid. If Agent terminates this Agreement, Agent will refund a prorated portion of the Fees.

7. GENERAL. This Agreement shall be construed and enforced in accordance with the laws of Florida. Company acknowledges that the duties of Agent under this Agreement are limited to those set forth in the Regulation and that Agent is not involved in the formulation, sourcing, promotion, marketing, inspection, quality control, sale, or manufacture of Company’s products. Company shall defend, indemnify and hold Agent harmless from any and all claims arising in connection with the Company or any of its products. In the event of any dispute under this Agreement, the prevailing party shall be entitled to recover reasonable attorneys fees and costs directly related to the dispute. Any notice required or permitted under this Agreement may be sent by: first class mail (postage prepaid and marked for delivery by certified or registered mail, return receipt requested); nationally-recognized overnight courier; fax; email; or by personal delivery. Such notice shall be deemed delivered upon: personal delivery; 3 days after deposit during business hours with a nationally recognized overnight courier; upon actual confirmation of receipt by any other means. This Agreement constitutes the total agreement between the parties and all prior discussions are incorporated herein. This Agreement may be modified only by a further writing that is duly executed by both parties.

8. AGREEMENT. By clicking below, Company agrees to be bound by the terms of this Agreement.

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)

From:

- -

To:

- -

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SECTION 9:

TYPE OF ACTIVITY CONDUCTED AT THE FACILITY

(Check ALL TYPES OF OPERATION THAT ARE PERFORMED AT THIS FACILITY REGARDING THE MANUFACTURING/PROCESSING, PACKING OR HOLDING OF FOOD)

Warehouse / Holding Facility	Animal Food manufacturer / processor / holder
Acidified/Low Acid Food Proc.	Labeler / Relabeler	Interstate Conveyance Caterer/Point
Manufacturer / Processor	Repacker / Packer	Molluscan Shellfish Establishment
Commissary	Contract Sterilizer	Salvage Operator (Reconditioner)

SECTION 10: (Optional)

TYPE OF STORAGE (For facilities that are primarily holders)

Refrigerated Storage

Frozen Storage

Ambient (neither frozen nor refrg.)

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SECTION 11a:

GENERAL PRODUCT CATEGORIES - FOOD FOR HUMAN CONSUMPTION

To be completed by all food facilities.

01. Alcoholic beverages	02. Baby (Infant and Junior) Food Products
03. Bakery Products, Dough Mixes, or Icings	04. Beverage Bases
05. Candy without chocolate, Candy specialties	06. Cereal Prep, Breakfast foods, instant cereals
07. Cheese and Cheese products	08. Chocolate and cocoa products
09. Coffee and tea	10. Color additives for foods
11. Dietary conventional foods or meal replacement	12. Dietary Supplements (see 12a. thru 12d)
12a. - Proteins, Amino Acids, Fats & Lipid sub.	12b. - Vitamins and Minerals
12c. - Animal By-Products and extracts	12d. - Herbals and Botanicals
13. Dressings and Condiments	14. Fishery/Seafood products
15. Food Additives, safe (GRAS) ingredients	16. Food Sweeteners (Nutritive)
17. Fruits and fruit products	18. Gelatin, rennet, pudding mixes or pie filling
19. Ice Cream and related products	20. Imitation milk products
21. Macaroni or noodle products	22. Meat, meat products and poultry (FDA Reg.)
23. Milk, butter or dried milk products	24. Multiple food dinners, gravies, sauces
25. Nut and edible seed products	26. Prepared salad products
27. Shell egg and egg products	28. Snack food items (flour, meal or veg. base)
29. Spices, flavors, and salts	30. Soups
31. Soft Drinks and Waters	32. Vegetables and vegetable products
33. Vegetable Oils (Incl. Olive Oil)	34. Veg. Protein products (Simulated meats)
35. Whole grains, miller grain products	36. Most / all human food products categories
37. NON OF THE ABOVE MANDATORY CATEGORIES

SECTION 11b: (Optional)

GENERAL PRODUCT CATEGORIES - FOOD FOR ANIMAL CONSUMPTION

01. Grain products (ie barley, grain, sorghums, maiz etc.)	02. Oilseed products (cottonseed, soybeans etc)
03. Alfalfa and lespedeza products	04. Amino Acid
05. Animal-Derived products	06. Brewer products
07. Chemical preservatives	08. Citrus products
09. 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 waster 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

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Owner's Name:

Provide the following address information of owner, operator or agent in charge, if different from all other sections on the form. If information is the same as another section of the form, check which section:

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Section2: Facility

Section 3: Mail Address

Section 4: (Parent Co.)

or fill-in address below

Street Address: Line 1

Street Address: Line 2

City:

State:

Postal Code:

Province/Territory:

Country:

Phone No.:

Fax No.:

e-Mail Address:

SECTION 13:

CERTIFICATION STATEMENT

Peter H. Sorensen of Lalandia, Inc. (Agent), who is hereby duly authorized by the owner, operator, or agent in charge of the facility, as per Section 12 above, must submit this form to the FDA. By submitting this form to the FDA, or by authorizing an individual to submit this form to the 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. (En español)

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Name of authorizing individual of the owner, operator or agent in charge:

SECTION 14:

CREDIT CARD INFORMATION

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Credit Card Type:

American Express MasterCard Visa

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Credit Card Number:

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Expiration Date:

A charge of US 350.00 will be charged to the above credit card covering the first year as your F.D.A. U.S. Agent, as per agreement. Prior Notice filing fee of US$ 15.00 for each FDA issued Prior Notice confirmation No., will be charged separately or on a monthly basis, based on Prior Notice filing volume.

Upon pressing the Submit button below, a confirmation page will show-up with all agreement text, certification statement and any information supplied by you. We recommend that you print out this confirmation page for your records. Upon receipt, Lalandia will verify your data and confirm the registration via e-mail. A separate e-mail will be sent to you and Lalandia directly from the FDA with your new FDA Facility Registration Number (FFRN) .

Once you have submitted your form 3537 by clicking on the above "Submit Form 3537" button, you can file you first Prior Notice by clicking here

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