FDA warns businesses across the US of import 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.


Jap Inc. dba Intercontinental Foods
Ferndale, WA

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

In a May 24, 2022 warning letter, the FDA described a March 8-9, 2022 Foreign Supplier Verification Program (FSVP) inspection of Jap Inc. dba Intercontinental Foods in Ferndale, WA.

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:

  • Brooke Bond Taj Mahal 450G imported from (redacted)situated in (redacted)
  • Brooke Bond Red Label Tea 1800G imported from (redacted)situated in (redacted)
  • Lipton Yellow Label Tea 450G imported form (redacted)situated in (redacted)
  • chilli powder imported from (redacted)situated in (redacted)

The full warning letter can be viewed here.

Regino Produce LLC
Houston, TX

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

In a June 27, 2022 warning letter, the FDA described an April 5-11, 2022 Foreign Supplier Verification Program (FSVP) inspection of Regino Produce LLC in Houston, TX.

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:

  • Ready-to-eat fried corn chips imported from (redacted)situated in (redacted)
  • Fresh raw Serrano peppers imported from (redacted)situated in (redacted)
  • Fresh raw lettuce imported from (redacted)situated in (redacted)

Additional comments:

The company imports serrano peppers, lettuce, and other raw agricultural products, which are “covered commodities” within the meaning of 21 CFR 112.3. Their FSVP must provide adequate assurance that the processes and procedures their supplier uses provide the same level of public health protection as required and the regulations implementing the Standards for Growing, Harvesting, Packaging and conservation of products intended for human consumption.

The full warning letter can be viewed here.

Imports of fresh products
Los Angeles, CA

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 May 10, 2022 warning letter, the FDA described a January 25-27, 2022 Foreign Supplier Verification Program (FSVP) inspection of imports of Greenfield products in Los Angeles, 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:

  • Perishable and frozen cassava imported from (redacted)
  • Fresh young coconut without green husk imported from (redacted)
  • Fresh turmeric imported from (redacted)

Additional comments:

The company imports fresh produce, which is “covered produce” within the meaning of 21 CFR 112.3. Their FSVP must demonstrate that their supplier complies with the requirements of the Standards for the cultivation, harvesting, packaging and preservation of products intended for human consumption.

The full warning letter can be viewed here.

Dara Food LLC
Fairfield, New Jersey

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

In a May 31, 2022 warning letter, the FDA described a Foreign Supplier Verification Program (FSVP) inspection from February 17 to March 14, 2022 of Dara Food LLC in Fairfield, NJ.

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:

  • Confectionery (chocolate bars) imported from (redacted)
  • Sheep cheese imported from (redacted)
  • Baklava imported from (redacted)

During the inspection, the firm provided the investigator with the following documents:

  • For the confectionery they import from (redacted)the company has provided a health certificate issued by the (redacted)which states: “The company producing/importing the product, which is intended for export by the exporting company, has been subject to regular inspections by the food inspectors of (redacted) in terms of minimum technical and hygienic requirements and related legislation and, where appropriate, samples are taken from the products and analyzed by approved state laboratories or approved private food control laboratories”; and a document entitled “FSVP RECORD ITEM DETAILS” which provides information on the product, “Stick with chocolate, 400gr”, such as ingredients, nutritional information and organoleptic parameters.
  • For sheep’s milk from where you import (redacted)you have provided an International Veterinary Certificate of Origin and Health of the (redacted)which provides information about the animal from which the product is derived.
  • For the baklava from where you import (redacted)you have provided three health certificates issued by the (redacted)which state that “the company producing/importing the product, which is intended for export by the exporting company, has been subject to regular inspections by the food inspectors of (redacted) in terms of minimum technical and hygienic requirements and related legislation and, where applicable, samples are taken from the products and analyzed by approved state laboratories or approved private food control laboratories”; and a document entitled “FSVP RECORD ITEM DETAILS” which provides information about the product, “Frozen Baklava with Pistachio”, such as ingredients, nutritional information and organoleptic parameters.

The full warning letter can be viewed here.

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