FDA WARNING_LETTER - Three Sister's Snacks Corporation - June 26, 2008

The FDA conducted an inspection of Three Sisters Snacks Corporation, a manufacturer and distributor of fried plantain chips, on June 25-26, 2008. The inspection and subsequent review of a product label revealed that the Plantain Chips are misbranded under section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 343(q)(1)) and 21 CFR 101.9. The product label lacks required nutrition labeling, including proper serving size, number of servings, total calories, and amounts of required nutrients.

Additionally, the ingredient statement for the Plantain Chips incorrectly declares the oil ingredient(s). According to 21 CFR 101.4(b)(14), each individual oil ingredient must be declared by its specific common or usual name, and if multiple oils are used interchangeably, they must be identified with "or," "and/or," or "contains one or more of the following."

During the inspection, a Form FDA-483, Inspectional Observations, was issued, detailing observations related to current good manufacturing practice (CGMP) requirements (21 CFR Part 110). The FDA expects prompt corrective action for all violations and a written response within 15 working days detailing steps taken, including documentation like revised labels, to correct the misbranding and prevent recurrence. Failure to comply may