As part of its enforcement activities, the Food and Drug Administration issues warning letters to entities under its jurisdiction. Some letters are only made available to the public 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. The FDA frequently redacts portions of warning letters posted to the public.
Patidar Trade, Inc.
North Brunswick, NJ
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 January 6, 2022 warning letter, the FDA described a Foreign Supplier Verification Program (FSVP) inspection from August 10 to September 10, 2021 of Patidar Trade, Inc. in North Brunswick, 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:
- Wheat flour imported from (redacted)
- Rice flour imported from (redacted)
- Phool makhana imported from (redacted)
The FDA also noted that certain foods imported from the company’s overseas supplier (redacted) are currently under Detention Without Physical Examination (DWPE) based on several Import Alerts (IA):
- IA #45-02, for foods containing illegal and/or undeclared dyes;
- IA #99-08, for human and animal processed foods for pesticides
- AI #99-19, for food products due to the presence of Salmonella;
- IA #99-21, for food products containing sulphites.
Therefore, when the company imports these foods subject to the DWPE as described in these identified AIs, they are refused admission to the extent that the food appears to be adulterated and/or mislabelled.
The full warning letter can be viewed here.
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