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July 16, 2021

Re: CMS # 614357

Dear Mr. Su:

From February 26 to March 5, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of TRANSU INVESTMENT GROUP, LLC, located at 1386 Belt Line Rd, Richardson, Texas. We also conducted an inspection on March 4, 2019. 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 your pineapple syrup and red beans imported from your foreign supplier (b)(4) located in (b)(4) and your honey syrup imported from your foreign supplier (b)(4) located in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of both the initial FSVP inspection on March 4, 2019 and the follow up inspection on March 5, 2021, our investigator provided you, in each instance with a Form FDA 483a, FSVP Observations. An amended FDA 483a, FSVP Observations was issued to you by our investigator on April 30, 2021.

As of the date of this letter, we have not received your response to the amended Form FDA 483a dated April 30, 2021.

Your significant violations of the FSVP regulation are as follows:

1. You did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis, as required by 21 CFR 1.504(d). In accordance with 21 CFR 1.504(a), you must conduct a hazard analysis for each food you import to determine whether there are any hazards requiring a control. Although you may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity, using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During the inspection, you provided copies of your foreign supplier (b)(4) hazard analysis for pineapple syrup and red beans, and your foreign supplier (b)(4) hazard analysis for honey syrup. However, for each of these foods, you did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual, as required by 21 CFR 1.504(d).

2. You must approve your foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a). Although you may meet this requirement by reviewing and assessing the evaluation conducted by another entity (other than your foreign supplier) using a qualified individual, you must document your review and assessment of that evaluation, including documenting that the evaluation was conducted by a qualified individual (21 CFR 1.505(d)). During the inspection, you told our investigator that another entity conducted an evaluation of your foreign suppliers (b)(4). However, you did not provide documentation that you have reviewed and assessed that entity’s evaluation and that the evaluation was conducted by a qualified individual, as required by 21 CFR 1.505(d).

3. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document your use of these procedures, as required by 1.506(a)(1).

4. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import, as required by 21 CFR 1.506(b).

5. You did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from a foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). Specifically, for your pineapple syrup and red beans from (b)(4) and your honey syrup from (b)(4), you did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c).

6. For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). However, you did not verify and document that your red beans from (b)(4) were produced in accordance with 21 CFR part 113, 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 take 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 the foods you import from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. 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.

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 would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised 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 # 614357 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
Program Division Director
Division of Southwest Imports