Fda 3613 Supplementary Information Certificate To Foreign Governm

Form Approved: 0MB No. 0910-0498; Expiration Date: 8/31/2021

SUPPLEMENTARY INFORMATION
CERTIFICATE TO FOREIGN GOVERNMENT REQUESTS

Department of Health and Human Services
Food and Drug Administration

Send the Expoti Cetiificate Requests and suppoiting documents to the appropriate Center within FDA that would have
control over your product:
CBER: CBER regulates biological products, including blood and.blood products, vaccines, allergenics, tissues, and
cellular and gene therapies. CBER also regulates the medical devices involved in the collection, processing, testing,
manufacture and administration of licensed blood, blood components and cellular products and all HIV test kits used
both to screen donor blood, blood components, and cellular products and to diagnose, treat, and monitor persons with
HIV and AIDS. Please apply for your application using https://www.access.fda.gov/oaa. Please see page 8 for CBER
instructions on how to apply for this certificate.
CDRH: CDRH regulates devices ranging from thermometers to kidney dialysis machines and eleclrnnic products that
emit radiation such as microwaves. Please submit your application online using https://www.access.fda.gov/oaa.
Please see page 9 for CDRH instructions on how to apply for this certificate.
CVM: Feed/food, drugs and devices used in pets, farm animals, and other animals are regulated by the Food and
Drug Administration, Center for Veterinary Medicine, Division of Compliance (HFV-234), 12225 Wilkins Avenue,
MPN4 #133, Rockville, MD 20852. If you have any questions, please email [email protected].
Please see page 10 for CVM instructions on how to fill out this form and apply for this certificate.

1A. Requestor Information

No Changes
Address

Name
Firm
_____________________________
Owner
operator number (if applicable)
Telephone number

A

FX number

1 B. Billing Address (if not the same as requestor)

Email address

Firm Tax ID code

No Changes

______________________________________________________
1C.
Shipping Account Number and/or Label (Mailing supplies may

be______________________
sent along with this form.)

Certificates will be issued electronically
Alternate Billing Email Address (if not the same as requestor)
2. Manufacturer Information (The following entries are to be entered separately for each firm; multiple entry sets are provided)
Address (P.O. Box not acceptable)

Firm or Firm Establishment Identifier (FEI)
________________________________________
Registration number/Firm Establishment Identifier (FEI)
______________________
License
number (if applicable)

___________________
Date
of last FDA inspection
(Item 4 entry sets continued, next page)

Center for Biologics Evaluation and
Research (CBER) instruc"tions
begin on page 8.

FORM FDA 3613 (2/19)

Center for Devices and Radiological
Health (CDRH) instructions
are on page 9.

Page 1 of 10

Center for Veterinary Medicine (CVM)
instructions are on page 10.

PSC Publishing &:t\'ices(l01)443-6740 EF

2. Manufacturer Information (Continued)
Firm

Same Changes from page 1
Address (P. 0. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)
License number (if applicable)

Date of last FDA inspection

Firm

Address (P. 0. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)
License number (if applicable)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)
License number (if applicable)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)
License number (if applicable)

Date of last FDA inspection
. .-.} )., .

Address (P.O. Box not acceptable)

Firm

Registration number/Firm Establishment Identifier (FEI)
License number (if applicable)

Date of last FDA inspection

3. Distributor Information (If applicable. Any firm listed must have a U.S. address.)
Address (P.O. Box not acceptable)
Firm or Firm Establishment Identifier (FEI)
__________________________________________
Registration number/Firm Establishment Identifier (FEI)

Proper name

Trade name

_______________________________
Mar eting application number (BLAISTN, HDE, NADA, ANADA, NDA, PDP, PMA, or 510k preamendment or exempt- Include number and date approved)
CVM will ask for Drug License/Approval number (NADA, ANADA, CNADA or National Drug Code (NDC)) as applicable

FORM FDA 3613 (2119)

Page 2 of 10

__
5A. Was the product ever recalled?

□

Sections 5A thru 5C will no longer be required
If "Yes", state the recall number and close-out date:

Yes

Close-out Dale

Recall Number

__
5A. Was the product ever recalled? (Continued)

(Note: Include recalls from the past 10 years.)
Close-out Dale

Recall Number

Close-out Date

Recall Number

__
5B. Are any of the manufacturers under Injunction?

D

D

Yes
No
If yes, provide registration or FEI number:

__
5C. Are any of the products under Seizure?
Yes
No
If yes, provide product name:

D

D

6. List country(ies) for which the Certificates are requested. List at least one country.

No Changes

t:1;.,11,

.' ;,•t '

7. Other information to appear on the certificate.

8._______________________________________________________________________________________________________
Should the country destination be listed on the certificate? (Note: CDRH does not list a specific country unless requested.)

D Yes

D No

FORM FDA 3613 (2/19)

Indicate the total number of certificates requested: --Page 3 of 10

�
-

CVM does not ask this question

EXPORTER'S CERTIFICATION STATEMENT
"CERT/FICA TE TO FOREIGN GOVERNMENT"
forCVM

Department of Health and Human Services
Food and Drug Administration
FIRM NAME

As the responsible official or designee of the company named above, I hereby certify to the United States Food and
Drug Administration that the company, the manufacturing plant, and the product(s) being expo1ted, as identified in the
Application, continue to be, to the best ofmy knowledge, in compliance with all applicable requirements of the Federal
Food, Drug, and Cosmetic Act, and all applicable or pertinent regulations including the following:
1. Facilities that appear on the Application are currently registered with the FDA.
2 Each product(s) identified for expo1t is legally marketed within the United States.

3. Each product(s) identified is not the subject of an open recall or the subject ofany current enforcement action
initiated by FDA;
4. All manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process have
been identified on the Application;
5. The requesting facility and all facilities involved in the manufacturing process are operating in substantial
compliance with the Good Manufachiring Practices Regulation for the identified product(s); and
6. Each product(s) identified for expo1t is being exported from the United States.
SIGNATURE

NAME AND TITLE

---

-

.

DATE

,·

- - ... -

,·

-

..
..

I hereby make this certification of compliance statement for FDA with full knowledge that the making or submission
of false statements represent violations of the United States Code Title 18, Chapter 47, Section 1001. Penalties
include up to $250,000 in fines and up to five years imprisonment.
FORM FDA 3613 (2/19)

Page 4 of 10

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