- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameJose R. Sanchez
- Tuty Usa LLC
1625 Airport Road
Conroe, TX 77301-3125
- Issuing Office:
- Division of Southwest Imports
June 09, 2021
Re: CMS # 614625
Dear Mr. Sanchez:
From March 29 to April 14, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Tuty USA LLC located at 1625 Airport Road, Conroe, Texas. We also conducted an inspection on November 7, 2018. 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 are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products that you import, including but not limited to your wheat snacks and Japanese peanuts imported from your foreign supplier (b)(4) and Blackberry Tartlet Cookies imported from your foreign supplier (b)(4). You did not have FSVPs for these products or for any other products you import. 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 inspection on November 7, 2018 and the follow-up inspection on April 14, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge your email response, dated April 15, 2021, where you informed us that you “have started to work to implement the program and obtain the required documentation” and have hired someone who will implement this program and get the documents ready. You did not provide any additional details, supporting documentation, or a timeframe for implementing your FSVP program.
Your significant violations of the FSVP regulation are as follows:
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, maintain, and follow an FSVP for any of the food products you import, including but not limited to your wheat snacks and Japanese peanuts imported from (b)(4) and Blackberry Tartlet Cookies imported from (b)(4).
On April 2, 2021, you emailed our investigator certificates of analysis for “Japanese Style Peanut” and “Snacks Tuty,” a food defense plan for (b)(4) and a (b)(4) for (b)(4). You did not provide an explanation of these documents, describe how they would apply to your FSVP program, state that they constitute your FSVP program, or provide a record of your review of these documents. These documents alone do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).
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.
In addition, FDA has determined that (b)(3)(A).
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter 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 products you import for which you appear to be in violation of section 805. We may place the foods you import 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 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 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: Melissa G. Gonzalez, Compliance Officer, the Division of Southwest Imports, 216 West Village Blvd, Suite 107, Laredo, Texas 78041. If you have any questions regarding this letter, you may contact Melissa G. Gonzalez via email at firstname.lastname@example.org. Please reference CMS # 614625 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Program Division Director
Division of Southwest Imports