- Delivery Method:
- VIA EMAIL AND UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameGurjeet “Gary” Taneja
- Transworld International Trading Corp.
566 7th Ave, 8th Floor Room 804
New York, NY 10018-1802
- Issuing Office:
- Division of Northeast Imports
July 5, 2022
Re: CMS 629674
Dear Mr. Taneja:
On January 13 through February 18, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Transworld International Trading Corp. located at 566 7th Ave, 8th Floor Room 804, New York, NY. We also conducted an inspection on October 24, 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 are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import, including but not limited to (b)(4) imported from (b)(4), located in (b)(4); (b)(4) chocolate from the foreign supplier (b)(4), located in (b)(4); (b)(4) chocolate from the foreign supplier (b)(4), located in (b)(4), and puffed snacks botanas (tortilla chips) from the 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 the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.
We have not received your response to the Form FDA 483a issued on February 18, 2022.
Your significant violation of the FSVP regulation is 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, maintain, and follow an FSVP for some of the foods you import, including each the following food products:
• (b)(4) imported from (b)(4), located in (b)(4)
• (b)(4) chocolate imported from (b)(4) located in (b)(4)
• (b)(4) chocolate imported from (b)(4), located in (b)(4)
2. 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 the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). Specifically, for your puffed snacks botanas (tortilla chips) from your foreign supplier (b)(4), located in (b)(4), while your Standard Operating Procedure for your Foreign Supplier Verification Program (FSVP) states your verification activities for FSVP are review of the foreign supplier’s relevant food safety records and onsite third party audits, it does not state the frequency with which these audits must be conducted, as required by 21 CFR 1.506(d).
3. You did not meet the requirement to perform foreign supplier verification activities in accordance with 21 CFR 1.506(e) for the products you import. Specifically, for your puffed snacks botanas (tortilla chips) from your foreign supplier (b)(4), located in (b)(4), your Standard Operating Procedure for your Foreign Supplier Verification Program (FSVP) states your verification activities for FSVP are review of the foreign supplier’s relevant food safety records and onsite third party audits. You initially provided, as part of your FSVP records, a copy of a third party food safety audit report of your supplier (b)(4) for which the certificate expiry date was October 9, 2021. When our investigator inquired about the expired audit report you provided a more recent food safety audit report from a third party onsite audit performed on December 21 – 23, 2020 with a certificate that is valid through October 2024. However, you did not provide any documentation that you reviewed and assessed the results of that new audit report. While you may rely on supplier verification activities conducted in accordance with 21 CFR 1.506(e)(1) by another entity, you must promptly review and assess the results of the verification activities conducted by another entity and document your review and assessment (21 CFR 1.506(e)(3)).
In addition, although the audit reports provided do appear to be food safety system certifications, the reports and certifications do not indicate that they assessed compliance with FDA food safety regulations in accordance with 21 CFR 1.506(e)(1)(i)(B).
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. 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. We may place the foods you import on detention without physical examination (DWPE) when you import the foods. 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)).
In addition, we have the following comments regarding your written hazard analysis and unique facility identifier:
1. Based upon the documentation provided for your puffed snacks botanas (tortilla chips) from your foreign supplier (b)(4), located in (b)(4) it is not clear that the hazard analysis in your FSVP document or the hazard analysis in the third party audit report for the tortilla chips identified and evaluated all potential hazards. For example, it appears from the third party audit report that seasonings and flavorings may be added after the cook step. If so, the flavorings and seasonings would need to be pathogen free (and allergen free) prior to the addition onto the chips. These hazards, along with all other potential hazards, should be evaluated in any hazard analysis you write or review with a probable supply chain control for these seasonings and flavorings. We recommend you follow up with your foreign supplier to determine if these hazards have been evaluated and, if necessary, controlled. For further information about potential hazards for foods and processes, please see Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry at https://www.fda.gov/media/99581/download.
2. For each line entry of food product offered for importation into the United States, the importer’s name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying them as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection, as required by 21 CFR 1.509(a). Previously, FDA had issued guidance dated March 2018 which provided for the temporary use of the entity role code “UNK” (to represent “unknown”) in lieu of a DUNS number, to be provided in the Entity Number field for importer identification when filing entry with CBP for a food subject to FSVP. However, in April 2022, FDA issued new guidance, Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation. Accordingly, beginning on July 24, 2022, FSVP importers must comply with the requirement in 21 CFR 1.509(a) of providing a unique facility identifier recognized as acceptable by FDA when filing entry with CBP.
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: Slater Bartlett, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) email@example.com. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at firstname.lastname@example.org. Please reference CMS # 629674 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
CAPT Nazmul Hassan
Program Division Director
Division of Northeast Imports