Custer Dairy Processing Plant - 532771 - 10/05/2017

October 4, 2017

WARNING LETTER 532771

UNITED PARCEL SERVICE
Delivery Signature Requested

Eric C. Goan, Manager
Mississippi State University Dairy Plant
945 Stone Boulevard
Mississippi State, Mississippi 39762

Dear: Mr. Goan:

On June 19-21, 2017, investigators with the U.S. Food and Drug Administration (FDA) inspected your dairy product manufacturing facility, located at 945 Stone Boulevard, Mississippi State, Mississippi. During the inspection, our investigator reviewed labeling for your Mississippi State University ice cream products. Your Vanilla, Chocolate, Strawberry, Muscadine Ripple, Chocolate Almond, Chocolate Chocolate Chip, Chocolate Chip, Cookies and Cream, Butter Pecan, Praline Pecan, and Coffee flavored ice cream products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) in that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and the implementing regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and the CFR through links on FDA’s home page at www.fda.gov.

Your significant labeling violations are as follows:

Your firm’s Mississippi State University brand ice cream products in 6 fl oz and ½ gallon sizes are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition information (e.g. Nutrition Facts Panel) as required by 21 CFR 101.9.

Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18) [or see http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm053857.htm] for information on filing for an annual exemption.

The application may be submitted online at: https://www.accessdata.fda.gov/scripts/NLE/client/login.cfm.

We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.

Your firm’s 3 gallon Mississippi State University brand ice cream product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. §343(e)(1)] because the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The responsible firm should be identified by name and if the identified name is not the manufacturer the relationship of the identified name to the product must be disclosed.

We also note that the statement of the place of business does not include a street address for your 6 fl oz and ½ gallon Mississippi State University brand ice cream products. The street address may only be omitted if it is shown in a current city directory or telephone directory as required by 21 CFR 101.5(d).

Your firm’s Mississippi State University brand ice cream products in 6 fl oz, ½ gallon and 3 gallon sizes are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the label fails to bear a complete list of all ingredients by common or usual name, as well as all sub-ingredients, as required under 21 CFR Part 101.4.These product labels do not bear an ingredient statement, as required in 101.4(a)(1).

Your firm’s 3 gallon Mississippi State University brand ice cream product is misbranded within the meaning of Section 403(e)(2) [21 U.S.C. §343(e)(2)] of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with the provisions of 21 CFR 101.7.

Your firm’s 3 gallon container is misbranded within the meaning of Section 403(i)(1) [21 U.S.C. §343(i)(1)] of the FD&C Act in that the label fails to bear the common or usual name of the food.

Your firm’s Mississippi State University brand ice cream products in 6 fl oz, ½ gallon and 3 gallon sizes are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergens as required by section 403(w)(1) of the Act.

Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as “major food allergens.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:

The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or

The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].

Specifically, your products are ice cream a standardized food that is made with milk, and the labels fail to declare this allergen ingredient in accordance with the requirements of 403(w).

We also have the following comment:

The net quantity of contents in gallons or fluid ounces should be followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)].

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

We acknowledge receipt of your written response dated July 12, 2017 to the FDA 483 observations. The corrective actions to the CGMP violations appear to adequately address our concerns. However, only a future inspection will determine the merit of the corrective actions taken.

Section 743 of the Act [21 USC 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection which identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administration expenses incurred in connection with FDA’s arranging, conducting, and

evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 USC 379j-31(a)(2)(B)]. FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.

The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. You are requested to notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.

Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.

Please send your reply to Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Nashville, TN 37217. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.

Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East