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.
By George Food Specialties Inc.
Ballston Lake, NY
The FDA has issued a warning letter to By George Food Specialties Inc. for failing to comply with the Foreign Supplier Verification Program (FSVP) regulation. The letter, dated Dec. 23, 2024, follows an inspection conducted from Nov. 4 to Nov. 25, 2024, at the company’s Ballston Lake, NY, facility.
The FSVP regulation requires importers to verify that food brought into the United States meets U.S. safety standards. These measures are designed to ensure imported foods are produced under conditions equivalent to domestic regulatory requirements. According to the FDA, By George Food Specialties failed to develop, maintain, and follow an FSVP for any of the products it imports.
Inspection findings
The inspection revealed that the company did not have an FSVP in place for multiple imported products, including:
- Mayonnaise from two foreign suppliers located in different countries.
- Hot sauce from another foreign supplier.
At the conclusion of the inspection, the FDA issued a Form FDA 483a, listing the company’s significant violations.
FDA’s concerns
The FDA emphasized the critical nature of the violations, stating that the company’s lack of compliance could lead to unsafe products entering the U.S. market. Failure to address these issues could result in further enforcement actions, including refusal of admission for the implicated products or placement of the products on detention without physical examination (DWPE).
The agency noted that this warning letter is not an exhaustive list of violations and urged By George Food Specialties to take immediate corrective action to bring its operations into compliance.
The full warning letter can be viewed here.
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