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Cpr Ovisure

The document is a Certificate of Product Registration for a high-risk food product named OVISURE GOLD, a soy protein mixed beans and herbals drink mix, registered by YANI ONLINE STORE, OPC. It outlines the responsibilities of the manufacturer, including compliance with FDA regulations and the need for cooperation in post-marketing activities. The registration is valid from October 9, 2024, to October 9, 2026, and emphasizes the importance of truthful product information and adherence to labeling requirements.

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41 views2 pages

Cpr Ovisure

The document is a Certificate of Product Registration for a high-risk food product named OVISURE GOLD, a soy protein mixed beans and herbals drink mix, registered by YANI ONLINE STORE, OPC. It outlines the responsibilities of the manufacturer, including compliance with FDA regulations and the need for cooperation in post-marketing activities. The registration is valid from October 9, 2024, to October 9, 2026, and emphasizes the importance of truthful product information and adherence to labeling requirements.

Uploaded by

giakhanhvlogs
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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FDA Registration No.

: FR-4000012932702

CERTIFICATE OF PRODUCT REGISTRATION


(High Risk Food Product)

Pursuant to the provisions of Republic Act No.3720, otherwise known as the Food, Drugs and
Devices, and Cosmetic Act, as amended by Executive Order No. 175, and Republic Act No. 9711,
otherwise known as the Food and Drug Administration Act of 2009, and other applicable laws, rules and
regulations, the registration of the High Risk Food Product described hereunder is granted approval.

Brand Name: OVISURE GOLD


Product MSM SOY PROTEIN MIXED BEANS AND HERBALS DRINK MIX
Name:
Packaging: TIN CAN, 400 GRAMS NET WEIGHT
Company YANI ONLINE STORE, OPC, 93 KARUHATAN ROAD KARUHATAN,
Name and VALENZUELA CITY, METRO MANILA
Address:
LTO No.: CFRR-NCR-FI/E/W-857106
Manufacturer NATURE MADE PRODUCTION AND TRADING JOINT STOCK COMPANY, NO.
Name 277 DAO CAM MOC STREET, UY NO COMMUNE, DONG ANH DISTRICT, HANOI
and Address: CITY, VIETNAM

The company hereby ensures that they shall respond and cooperate fully with the FDA with
regard to any subsequent post-marketing activity initiated by the FDA. Further, the company shall be
responsible for ensuring that each batch/lot of the product continues to meet all the legal requirements, and
conforms to all the standards and specification of the product declared to the FDA, including compliance
to the list of obligations enumerated at the reverse side of this document.

The authorization is subject to suspension, cancellation, or recall should any violation of FDA
laws, and its implementing rules and regulations, involving the product be committed.

Issued on 09 October 2024 and valid until 09 October 2026 .

BY AUTHORITY OF THE DIRECTOR GENERAL


DECLARATION

I undertake to respond to and cooperate fully with Food and Drug Administration (hereafter referred to as
“THE AUTHORITY") with regard to any subsequent post-marketing activity initiated by the authority.

I undertake to ensure that the product’s technical and safety information is made readily available to the
authority concerned and to keep records of the distribution of the products for product recall purposes, and
other purposes as provided in existing laws, rules and regulations.

I undertake to notify the Authority of any adverse event, fatal or life threatening serious adverse event as
soon as possible by telephone, facsimile transmission, email or in writing, and in any case, no later than 48
hours after first knowledge.

I undertake to act immediately on potential food safety concerns should my product source or origin
declare/announce/notify a product recall order or any actions taken involving safety issues, and I am
responsible to stop distribution or remove product from the outlets or take appropriate actions and inform
the Authority on risk management actions undertaken and/or to be undertaken.

I declare that the particulars given in this product registration are true, all data, and information of
relevance in relation to the registration have been supplied and that the documents enclosed are authentic
or true copies.

I understand that I shall be responsible for ensuring that each consignment of my product continues to
meet all the legal requirements, and conforms to all the standards and specifications of the product that I
have declared to the Authority.

I understand that I cannot place reliance on the acceptance of my product registration by the authority in
any legal proceedings concerning my product, in the event that my product has failed to conform to any of
the standards or specifications that I had previously declared to the Authority.

I understand that I will need to comply with all the labeling requirements as stipulated by Administrative
Order No. 2014-0030 and other pertinent laws and regulations associated with labeling.

I undertake to declare truthful product information and shall not cause the dissemination of any false,
deceptive or misleading advertisement by print, radio, television, outdoor advertisement or other medium
for the purpose of inducing or which is likely to induce directly or indirectly the purchase of the product.

I understand that any change or variation in the formulation of registered product will require new
registration to the Authority and the subject shall be treated as new product.

I hereby agree and affirm full responsibility for the safety of my product/s and agree to indemnify and/or
hold FDA free and harmless against any issues that may arise in the manufacture, import, export,
distribute, transfer, promote, advertise, sponsor, sell, offer for sale, and where appropriate the use and
testing, and marketing of my food product/s

I hereby understand that the registration of the product herein granted shall not be interpreted or construed
as an endorsement or representation by FDA that I have the right or privilege to the use of the name or
brand so registered. I hereby agree and affirm to indemnify and/or hold FDA free and harmless against any
and all third-party claims on infringement of patent, trademark or intellectual property rights from the
registration of the product listed on the first page thereof.

REMARKS:

Declare "allergen/allergen information" preceding the list of allergens below the list of ingredients, and
nutrition information in prescribed format on the label.

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