California and New York import companies warned by FDA of violations

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


Transworld International Trading Corp.
New York, NY

A New York City import company is warned by the FDA that it does not have FSVPs for a number of imported food products.

In a July 5, 2022 warning letter, the FDA described a Foreign Supplier Verification Program (FSVP) inspection from January 13 to February 18, 2022 of Transworld International Trading Corp.

The FDA inspection revealed that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Significant offenses are:

1. The company has not developed, maintained and followed an FSVP. Specifically, it did not develop an FSVP for each of the following foods:

  • (Redacted) imported from (redacted)situated in (redacted)
  • (Redacted) chocolate imported from (redacted) situated in (redacted)
  • (Redacted) chocolate imported from (redacted)situated in (redacted)

2. The company has not met the requirement, before importing a food from a foreign supplier, to determine and document what verification activity(ies), as well as the frequency with which the activity or activities are to be carried out, are necessary to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with the regulations. Specifically, for their puffed snacks botanas – tortilla chips – from their overseas supplier (redacted)situated in (redacted)although their standard operating procedure for their FSVP indicates that their verification activities for the FSVP are the review of relevant foreign supplier food safety records and on-site third-party audits, it does not indicate the frequency at which these audits should be carried out.

3. The company has not met the requirement to conduct foreign supplier verification activities for the products it imports. Specifically, for their tortilla chips from their overseas supplier (redacted)situated in (redacted), their standard operating procedure for their FSVP indicates that their verification activities for FSVP are a review of relevant foreign supplier food safety records and on-site third-party audits. Company officials initially provided, as part of their FSVP records, a copy of a third-party food safety audit report from their supplier. (redacted) for which the certificate expiration date was October 9, 2021. When FDA investigators inquired about the expired audit report, company officials provided a more recent food safety audit report from third-party on-site audit conducted from December 21-23, 2020 with a certificate valid until October 2024. However, they have not provided any documentation that they have reviewed and assessed the results of this new audit report.

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

1. Based on the documentation provided for their puffed snacks botanas (tortilla chips) from their overseas supplier (redacted)situated in (redacted) it is not clear whether the hazard analysis in their FSVP document or the hazard analysis in the third-party audit report for tortilla chips identified and assessed all potential hazards. For example, it appears from the third-party audit report that seasonings and flavorings may be added after the cooking step. If so, the flavorings and seasonings should be free of pathogens (and allergens) before adding to the chips. These hazards, along with any other potential hazards, should be assessed in any hazard analysis they write or review with likely control of the supply chain for these seasonings and flavorings. The FDA recommends that they follow up with their foreign supplier to determine if these hazards have been assessed and, if necessary, controlled.

2. For each food product entry line offered for import into the United States, the importer’s name, email address, and unique facility identifier recognized as acceptable by the FDA, the identifier as the importer of the food, are provided electronically upon filing entry with US Customs and Border Protection, as required. Previously, the FDA issued guidance dated March 2018 that provided for the temporary use of the entity role code “UNK” (to represent “unknown”) instead of a DUNS number, to be provided in the Entity Number field. entity for importer identification upon filing entry with CBP for a food subject to FSVP. However, in April 2022, the 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, effective July 24, 2022, FSVP importers must comply with the requirement to provide a unique facility identifier recognized as acceptable by the FDA when filing a request with CBP.

The full warning letter can be viewed here.

Bolive inc.
Highland, California

An import company in California is warned by the FDA that it does not have an FSVP for a number of imported food products.

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

The FDA inspection revealed that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Significant offenses are:

The company has not developed, maintained and tracked an FSVP. Specifically, they did not develop FSVPs for each of the following foods:

  • (Redacted) halvah and (redacted) Tahini imported from a foreign supplier (redacted) in (redacted)
  • Black olives imported from a foreign supplier (redacted) in (redacted)

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, Click on here)

Comments are closed.