FDA warns Wisconsin importer to come into compliance with federal law

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.

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Indian Groceries and Spices Inc.
Oak Creek, WI

In an Oct. 18, 2023, warning letter the Food and Drug Administration outlined details of a June 26, 2023, to July 21, 2023, Foreign Supplier Verification Program (FSVP) inspection of Indian Groceries and Spices, Inc. located at 2025 W. South Branch Blvd., Chicago, IL 60646. The agency also conducted an inspection on September 1, 2021. 

These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. 

During the most recent inspection, the FDA found that the company is not in compliance with the requirements of 21 CFR part 1, subpart L for the foods it imports. Because of these significant violations, the company is not in compliance with section 805 of the FD&C Act.

At the conclusion of the FSVP inspection, our investigator provided company officials with a Form FDA 483a FSVP Observations. The agency has not received a response to the Form FDA 483a issued on July 21, 2023.

Significant violations of the FSVP regulation are as follows:

1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR §1.502(a). Specifically, you did not have an FSVP for any of the foods you import, including the following foods:

• Whole Cumin Seeds manufactured by (redacted by FDA)
• Extra Hot Chili Powder manufactured by (redacted by FDA)
• Green Mung Bean (Split Huskless) manufactured by (redacted by FDA)

To read the full warning letter, click here.

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