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.
Jap Inc. dba Intercontinental Foods
Ferndale, WA
An import company in Washington is on notice from the FDA for not having 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’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of a 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:
- Brooke Bond Taj Mahal 450G imported from (redacted), located in (redacted)
- Brooke Bond Red Label Tea 1800G imported from (redacted), located in (redacted)
- Lipton Yellow Label Tea 450G imported form (redacted), located in (redacted)
- Chilli Powder imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
Regino Produce LLC
Houston, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 27, 2022, warning letter the FDA described an April 5 and 11, 2022, Foreign Supplier Verification Program (FSVP) inspection of Regino Produce LLC in Houston, TX.
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:
- Fried Read-to-Eat Corn Chips imported from (redacted), located in (redacted)
- Fresh Raw Serrano Peppers imported from (redacted), located in (redacted)
- Fresh Raw Lettuce imported from (redacted), located in (redacted)
Additional comments:
The firm imports serrano peppers, lettuce, and other raw agricultural commodities, which are “covered produce” as defined in 21 CFR 112.3. Their FSVP must provide adequate assurance that the processes and procedures that their supplier uses provide the same level of public health protection as those required and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
The full warning letter can be viewed here.
Greenfield Produce Imports
Los Angeles, 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 May 10, 2022, warning letter, the FDA described a Jan. 25-27, 2022, Foreign Supplier Verification Program (FSVP) inspection of Greenfield Produce Imports in Los Angeles, 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:
- Perishable and frozen cassava imported from (redacted)
- Fresh young coconut without green husk imported from (redacted)
- Fresh turmeric imported from (redacted)
Additional comments:
The firm imports fresh produce, which is “covered produce” as defined in 21 CFR 112.3. Their FSVP must demonstrate their supplier is in compliance with the requirements of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
The full warning letter can be viewed here.
Dara Food LLC
Fairfield, NJ
An import company in New Jersey is on notice from the FDA for not having FSVPs for a number of imported food products.
In a May 31, 2022, warning letter the FDA described a Feb. 17 through March 14, 2022, Foreign Supplier Verification Program (FSVP) inspection of Dara Food LLC in Fairfield, NJ.
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:
- Confections (chocolate candy bars) imported from (redacted)
- Sheep’s milk cheese imported from (redacted)
- Baklava imported from (redacted)
During the inspection, the firm provided the investigator with the following documents:
- For the confections they import from (redacted), the firm provided a Health Certificate issued by the (redacted), which states, “The producer/importer company of the product, which is intended to be exported by the exporter company, has been undergoing regular inspections of the Food Inspectors of (redacted) in terms of minimum technical and hygienic requirements and related legislation and when necessary samples are taken from the products and analyzed by Authorized State Laboratories or Authorized Private Food Control Laboratories”; and a document titled “FSVP RECORD ITEM DETAILS” that provides information about the product, “Stick with chocolate, 400gr,” such as the ingredients, nutritional information, and organoleptic parameters.
- For the sheep’s milk you import from (redacted), you provided an International Veterinary Certificate of Origin and Health from the (redacted), which provides information on the animal from which the product was derived.
- For the baklava you import from (redacted), you provided three Health Certificates issued by the (redacted), which state, “The producer/importer company of the product, which is intended to be exported by the exporter company, has been undergoing regular inspections of the Food Inspectors of (redacted) in terms of minimum technical and hygienic requirements and related legislation and when necessary samples are taken from the products and analyzed by Authorized State Laboratories or Authorized Private Food Control Laboratories”; and a document titled “FSVP RECORD ITEM DETAILS” that provides information about the product, “Frozen Baklava with Pistachio,” such as the ingredients, nutritional information, and organoleptic parameters.
The full warning letter can be viewed here.
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