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WARNING LETTER

ITC Global Trading Inc. MARCS-CMS 615409 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
John Wong
Recipient Title
Manager
ITC Global Trading Inc.

1505 Sawyer St Ste B
Houston, TX 77007-4425
United States

Issuing Office:
Division of Southwest Imports Compliance Branch

United States

October 22, 2021


WARNING LETTER

Dear Mr. Wong: 

From April 30 to May 19, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of ITC Global Trading, Inc located at 1505 Sawyer St Ste B, Houston, Texas.  We also conducted inspections on August 4, 2017 and on February 24, 2020.  These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.  You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for the following the food you import, Canned Mango and Passion Fruit Drink, Water Chestnuts in Syrup, and Coconut Meat in Syrup. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with Form FDA 483a, FSVP Observations.  We have not received your response to the Form FDA 483a issued on May 19, 2021.

Your significant violations of the FSVP regulation are as follows:

1.    You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).  Specifically, you did not develop an FSVP for any of the foods you import, including the following foods:

•    Canned Mango and Passion Fruit Drink imported from (b)(4)
•    Water Chestnuts in Syrup imported from (b)(4)
•    Coconut Meat in Syrup imported from (b)(4)

2.    For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods) and with respect to the microbiological hazards associated with these food products, you must verify and document that they were produced in accordance with 21 CFR part 113.  Specifically, you did not verify and document that the canned food products you import, including but not limited to Water Chestnuts in Syrup and Coconut Meat in Syrup, were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements.  It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.  

This letter notifies you of our concerns and provides you an opportunity to address them.  If you do not adequately address this matter, we may result in further action.  For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805.   We may place all the food you import into the United States on detention without physical examination (DWPE).  You can find DWPE information relating to FSVP in Import Alert # 99-41, at http://www.accessdata.fda.gov/cms_ia/ialist.html.  In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).

You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should address the specific things you are doing to correct any violations.  You should include in your response documentation and information that will assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation.  If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your reply to Food and Drug Administration, Attention:  Virginia Ramos, Compliance Officer, the Division of Southwest Imports, 216 W. Village Blvd., Suite 107, Laredo, Texas 78041.  If you have any questions regarding this letter, you may contact Virginia Ramos via email at Virginia.Ramos@fda.hhs.gov.  Please reference CMS # 615409 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

 
Sincerely,
/s/
Todd Cato
Director, Southwest Imports


Cc:

Mr. Nikom Polvanich, President and Owner
1505 Sawyer St. Ste. B
Houston, TX 77007
(b)(6),(b)(7)(C)

 
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