FDA WARNING_LETTER - 88 Special Sweet, Inc. - January 21, 2020

On May 13, 2020, the FDA issued a Warning Letter to 88 Special Sweet, Inc. following Foreign Supplier Verification Program (FSVP) inspections on January 9 and 21, 2020, and a previous inspection on September 13, 2018. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L.

The FDA found that 88 Special Sweet, Inc. is not in compliance with FSVP requirements for imported food products, specifically Sunny Popping Balls (Boba) Strawberry Flavor from one foreign supplier and Mango Syrup and Passion Fruit Jam from another. The significant violation identified is the failure to develop, maintain, and follow an FSVP, as required by 21 CFR 1.502(a), for these products. The firm did not respond to the Form FDA 483a observations issued after both the 2018 and 2020 inspections.

Failure to promptly correct these violations may lead to further FDA action, including refusal of admission for the implicated products under section 801(a)(3) of the FD&C Act and potential placement on detention without physical examination (DWPE) under Import Alert # 99-41. The importation of food without a compliant FSVP is