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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pyramid Sprouters

  

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142


September 14, 2009


WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Debra K. Anderson
President and Owner
Pyramid Sprouters
9073 13th Street SE
Buffalo, Minnesota 55316


Dear Ms. Anderson:


Refer to MIN 09 - 24


This letter is in reference to your firm's manufacture, distribution, and labeling of various sprout products identified during our inspection conducted on April 27-30 and May 1, 2009, at your facility located at 9073 13th Street SE, Buffalo, Minnesota. The inspection and subsequent review of your labeling showed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, we found that your sprout products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a}(4)]. Additionally, some of your products are misbranded under section 403 of the Act [21 U.S.C. § 343].


Adulteration


Your sprout products are adulterated within the meaning of section 402(a}(4) of the Act [21 U.S.C. § (a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Examples of conditions which contribute to this determination are as follows:


• Your firm failed to effectively clean equipment prior to sanitizing. Calcium and residue build-up were observed on equipment and food contact surfaces such as sprayers and tubs.


• Your firm failed to provide any hand-washing facility for the washing of hands prior to production.


Misbranding


Your Spicy Sprouts Radish and Alfalfa Mix, Zesty Sprouts, and Crunchy Salad Sprouts products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the Nutrition Facts panels fail to declare trans fat, as required by 21 CFR 101.9(c)(2)(ii). Your Broccoli Sprouts product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] in that its label bears a nutrient content claim using the term "antioxidant," but fails to comply with regulations governing the use of such a claim. The labeling for this product does not declare as part of the claim the name(s) of the antioxidant nutrient(s) that are the subject of the claim as required by 21 CFR 101.54(g)(4), e.g., "High in antioxidant vitamin C."


Your Broccoli Sprouts, Broccoli Alfalfa Sprouts, Fresh Alfalfa Sprouts, and Wheat Grass Sprouts products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because their product labels fail to accurately declare the place of business, street address, city, state and zip code. The labels for these products in use at the time of the inspection list the location of the business as Rockford, Minnesota 55373. However, your business is currently located in Buffalo, Minnesota 55313.


Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation 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.


Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.


Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District


TSW/ccl