Inspections, Compliance, Enforcement, and Criminal Investigations
Three Sister's Snacks Corporation 31-Oct-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 31, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 03
Three Sisters Snacks Corporation, also known as Three Sister's Snacks
530 West Main Street
Anoka, Minnesota 55303
Dear Ms. Sphabmisay:
The U. S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 530 West Main Street, Anoka, Minnesota, on June 25 and 26, 2008. The inspection verified that your firm manufactures and distributes fried plantain chips. During the inspection, we collected a sample label from your Plantain Chips product. Based, on our review of your product label and other evidence collected during and after the inspection, your Plantain Chips are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 343). Regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You can find the Act and FDA regulations on the Internet through links on the FDA web page at www.fda.gov.
Specifically, your Plantain Chips are misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] because the label fails to bear nutrition labeling as required by such section (see also 21 CFR 101.9), and the product is not exempt from section 403(q)(1) of the Act under section 403(q)(5) of the Act [21 U.S.C. § 343(q)(5)]. Your Plantain Chips product label lacks required nutrition information including, for example, the proper serving size, number of servings, total number of calories, and the amounts of the required nutrients in each serving size of the food.
The violation described above is not meant to be an all-inclusive statement of deficiencies that may exist for your product, or for its labeling. It is your responsibility to ensure that your product is in compliance with the Act and its implementing regulations. You should take prompt action to correct the violation described above and to prevent its recurrence. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
Please advise this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken or will be taking to correct this violation, including the steps taken to ensure that similar violations do not recur. You should include in your response documentation of your corrective actions, such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
In addition to the above violation, we also comment that the ingredient statement for your Plantain Chips incorrectly declares the oil ingredient(s) used in your product. According to 21 CFR 101.4(b)(14), each individual oil ingredient must be declared by its specific common or usual name (e.g., soybean oil and hydrogenated soybean oil). Oil ingredients not present in the product may be listed if they may sometimes be used in the product and must be identified by words indicating that they may not be present, such as "or," "and/or," or "contains one or more of the following."
Furthermore, our investigator issued a Form FDA-483, Inspectional Observations, at the end of the inspection, and discussed these observations with you at that time. The observations listed on the FDA-483 pertain to requirements for current good manufacturing practice (CGMP) in manufacturing, packing, or holding human food (21 CFR Part 110). Your ability to comply with these requirements, specifically those discussed during-the inspection, will be observed during a future inspection.
Your written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, at the address on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
W. Charles Becoat