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. The FDA frequently redacts parts of warning letters posted for public view.
Patidar Trade, Inc.
North Brunswick, 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 Jan. 6, 2022, warning letter the FDA described an Aug. 10 through Sept. 10, 2021, Foreign Supplier Verification Program (FSVP) inspection of Patidar Trade, Inc. in North Brunswick, 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:
- 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 firm’s foreign supplier, (redacted), are currently subject to detention without physical examination (DWPE) based on multiple Import Alerts (IA):
- IA #45-02, for foods containing illegal and/or undeclared colors;
- IA #99-08, for processed human and animal foods for pesticides
- IA #99-19, for food products due to the presence of Salmonella;
- IA #99-21, for food products containing sulfites.
Therefore, when the firm imports these foods subject to DWPE as described in these identified IAs, they are subject to refusal of admission in that the food appears to be adulterated and/or misbranded.
The full warning letter can be viewed here.
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