FDA WARNING_LETTER - Indian Groceries and Spices, Inc. - July 21, 2023

On October 18, 2023, the FDA issued a Warning Letter to Indian Groceries and Spices, Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from June 26 to July 21, 2023, at their Chicago, IL location. A previous inspection occurred on September 1, 2021. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1, subpart L).

The FDA found significant violations, specifically that the company failed to develop, maintain, and follow an FSVP for any imported foods, including those listed in the letter. This violates section 805 of the FD&C Act and 21 CFR §1.502(a). An FDA Form 483a FSVP Observations was issued on July 21, 2023, but no response has been received.

Failure to adequately address these violations may lead to further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert # 99-41. Importing food without a compliant FSVP is also prohibited under section 301(zz) of the FD&