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.
Eco Food Distribution LLC
Schiller Park, IL
An import company in Illinois is on notice from the FDA for not developing an FSVP for the foods they import.
In a May 25 warning letter, the FDA described a Feb. 28 through March 29 Foreign Supplier Verification Program (FSVP) inspection of Eco Food Distribution LLC in Schiller Park, IL.
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. Some of the significant violations are as follows:
1. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for the foods they import from the foreign suppliers indicated.
2. The firm did not conduct a written hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not provide a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards for the food they import to determine whether there are any hazards requiring a control, as required.
3. The firm did not approve their foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their approval. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not provide documentation that they have evaluated their foreign supplier’s performance and risk posed by the food or their approval of these suppliers.
4. The firm did not perform foreign supplier verification activities. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not 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 they obtain from the foreign supplier is produced in accordance with regulation. In addition, they did not conduct and document (or obtain documentation of) one or more of the supplier verification activities for each of these foreign suppliers before importing these foods and periodically thereafter.
The full warning letter can be viewed here.
Moises Gardea
Albuquerque, NM
An import company in New Mexico is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 12 warning letter, the FDA described a March 9-24 Foreign Supplier Verification Program (FSVP) inspection of Moises Gardea in Albuquerque, NM.
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:
- Asadero Cheese, Solid imported from (redacted), located in (redacted)
- Mennonite Cheese imported from (redacted), located in (redacted)
- Asadero Cheese, Tortilla Style imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
FVD Produce LLC
Pharr, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Aug. 15 warning letter, the FDA described a Feb. 8 and March 9 Foreign Supplier Verification Program (FSVP) inspection of FVD Produce, LLC in Pharr, 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. Some of 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:
- Fresh tomatoes, husk tomatoes, carrots and various onions from (redacted), located in (redacted)
- Carrots from (redacted) located in (redacted)
The full warning letter can be viewed here.
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