Food & Drinks

Import companies in California and New York warned by FDA over violations

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.


Transworld International Trading Corp.
New York, NY

An import company in New York City is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 5, 2022, warning letter the FDA described a Jan. 13 through Feb. 18, 2022, Foreign Supplier Verification Program (FSVP) inspection of Transworld International Trading Corp.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

1. The firm did not develop, maintain, and follow an FSVP. Specifically, it did not develop an FSVP for each of the following foods:

  •  (Redacted) imported from (redacted), located in (redacted)
  • (Redacted) chocolate imported from (redacted) located in (redacted)
  • (Redacted) chocolate imported from (redacted), located in (redacted)

2. The firm 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 regulation. Specifically, for their puffed snacks botanas — tortilla chips — from their foreign supplier (redacted), located in (redacted), while their Standard Operating Procedure for their FSVP states their 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.

3. The firm did not meet the requirement to perform foreign supplier verification activities for the products they import. Specifically, for their tortilla chips from their foreign supplier (redacted), located in (redacted), their Standard Operating Procedure for their FSVP states their verification activities for FSVP are a review of the foreign supplier’s relevant food safety records and onsite third party audits. Company officials initially provided, as part of their FSVP records, a copy of a third-party food safety audit report of their supplier (redacted) for which the certificate expiry date was Oct. 9, 2021. When FDA investigators inquired about the expired audit report company officials provided a more recent food safety audit report from a third-party onsite audit performed on Dec.  21-23, 2020 with a certificate that is valid through Oct. 2024. However, they did not provide any documentation that they reviewed and assessed the results of that new audit report.

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In addition, the FDA  has the following comments regarding the firm’s written hazard analysis and unique facility identifier:

1. Based upon the documentation provided for their puffed snacks botanas (tortilla chips) from their foreign supplier (redacted), located in (redacted) it is not clear that the hazard analysis in their 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 to the chips. These hazards, along with all other potential hazards, should be evaluated in any hazard analysis they write or review with a probable supply chain control for these seasonings and flavorings. FDA recommends they follow up with their foreign supplier to determine if these hazards have been evaluated and, if necessary, controlled.

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 the FDA, identifying them as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection, as required. 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 of providing a unique facility identifier recognized as acceptable by the FDA when filing entry with CBP.

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The full warning letter can be viewed here.

Bolive Inc.
Upland, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 5, 2022, warning letter, the FDA described a Feb. 22, 2022, Foreign Supplier Verification Program (FSVP) inspection of Boline Inc. in Upland, CA.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

  • (Redacted) Halva and (redacted) Tahini imported from foreign supplier (redacted) in (redacted)
  • Black Olives imported from foreign supplier (redacted) in (redacted)

The full warning letter can be viewed here.

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