FDA WARNING_LETTER - Blue Stone Import USA Inc. - June 06, 2022

On May 25, 2022, through June 6, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of BLUE STONE IMPORT USA INC. This was the third inspection, with previous inspections on May 2, 2019, and February 3, 2021. The inspection 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 that BLUE STONE IMPORT USA INC is not in compliance with 21 CFR part 1, subpart L, and section 805 of the FD&C Act. A significant violation identified was the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported food products. The company did not respond to the Form FDA 483a FSVP Observations issued on June 6, 2022.

Failure to 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 placement of imported foods on detention without physical examination (DWPE) under Import Alert # 99-41. The importation of food without a compliant FSVP is