FDA puts Texas company on notice for failing to meet import regulations

Shantaba LLC
Austin, TX

On June 30, 2023, through July 7, 2023, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Shantaba LLC at 2506 W Parmer Lane, Ste 170, Austin, TX. The inspectors also conducted an inspection on June 8 and 9, 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 Foreign Supplier Verification Program (FSVP) implementing 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 you import.

At the conclusion of the inspection, the FDA investigator provided the company with a Form FDA 483a FSVP Observations. The FDA has not received the company’s response to the Form FDA 483a issued on July 7, 2023.

Significant violation of the FSVP regulation is as follows:

The company 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, the company did not develop an FSVP for any of the foods it import, including the following foods:

• 2-Minute Noodles imported from (b)(4).
• Kesar Mango Pulp imported from (b)(4).
• Soya Wadi-Soya Chunks imported from (b)(4).

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is the company’s responsibility to ensure that it is in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.

The warning letter notifies the company of FDA’s concerns and provides the company an opportunity to address them. If the company does not adequately address this matter, the FDA may take further action. For instance, the agency may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food the company imports for which it appears to be in violation of section 805. The FDA may place the foods the company imports on detention without physical examination.

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