FDA Warning Letter for FSVP Violations

February 27, 2024

Oak Creek, WI – The Food and Drug Administration (FDA) recently issued a warning letter to Indian Groceries and Spices Inc., located at 2025 W. South Branch Blvd., Chicago, IL 60646, following a Foreign Supplier Verification Program (FSVP) inspection conducted from June 26, 2023, to July 21, 2023. This inspection aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation in 21 CFR part 1, subpart L.

The FDA also conducted a prior inspection on September 1, 2021, to evaluate the company’s adherence to food safety standards in the importation of human and/or animal food into the United States.

The agency identified significant violations during the recent inspection, and the company is found to be non-compliant with the FSVP regulation. As per the warning letter dated October 18, 2023, the key violations include:

  1. Lack of FSVP Development: Indian Groceries and Spices Inc. failed to develop, maintain, and follow an FSVP, contravening section 805 of the FD&C Act and 21 CFR §1.502(a). Notably, the company lacked an FSVP for any of the imported foods, including Whole Cumin Seeds, Extra Hot Chili Powder, and Green Mung Bean (Split Huskless).

The FDA emphasized that these violations jeopardize compliance with U.S. food safety standards, raising concerns about the safety and quality of the imported food products.

The FDA investigator provided the company officials with a Form FDA 483a FSVP Observations at the conclusion of the inspection on July 21, 2023. However, as of the issuance of the warning letter, the agency had not received a response from Indian Groceries and Spices Inc. regarding the observed violations.

Business owners typically have 15 days to respond to FDA warning letters, and failure to address and rectify these issues may result in further regulatory actions. It is crucial for companies to take prompt corrective measures to ensure compliance with FSVP requirements and uphold the safety of imported food products.

Read Full Warning Letter –https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indian-groceries-and-spices-inc-663853-10182023

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