As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not released to public view 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 the company has had months or years to correct the problems.
Jap Inc. dba Intercontinental FoodsFerndale, WA
An import company in Washington received a notification from the FDA for not having FSVPs for several 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 violations are as follows:
The company did not develop, maintain or follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
The full warning letter can be viewed here.
A Texas importing company received a notification from the FDA for not having FSVPs for a number of imported food products.
In a warning letter dated June 27, 2022, the FDA described an April 5-11, 2022 Foreign Vendor 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 violations are as follows:
The company did not develop, maintain or follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
The company imports serrano peppers, lettuce, and other raw agricultural products, which are “covered products” as defined in 21 CFR 112.3. Your FSVP must provide adequate assurance that the processes and procedures your supplier uses provide the same level of public health protection as those required and 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 ImportsLos Angeles, CA
A California importing company received a notification from the FDA for not having FSVPs for a number of imported food products.
In a May 10, 2022 warning letter, the FDA outlined a January 25-27, 2022 Foreign Vendor Verification Program (FSVP) inspection of fresh produce imports into Los Angeles, CA.
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 violations are as follows:
The company did not develop, maintain or follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
The company imports fresh produce, which is “covered produce” as defined in 21 CFR 112.3. Your FSVP must show that your supplier meets the requirements of the Standards for the Growing, Harvesting, Packing and Holding of Products for Human Consumption.
The full warning letter can be viewed here.
An import company in New Jersey is under FDA notification for not having FSVPs for a number of imported food products.
In a May 31, 2022, warning letter, the FDA described a Foreign Vendor Verification Program (FSVP) inspection from February 17 to March 14, 2022 of Dara Food LLC in Fairfield, New Jersey.
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 violations are as follows:
The company did not develop, maintain or follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
During the inspection, the firm provided the investigator with the following documents:
The full warning letter can be viewed here.
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