Inspections, Compliance, Enforcement, and Criminal Investigations
Mexican Village Wholesale Foods, Inc
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142
August 5, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 20
David S. Gordon
Mexican Village Wholesale Foods, Inc.
dba Full Service Foods
217 S. Main Street, P.O. Box 336
Hillsboro, North Dakota 58045-4425
Dear Mr. Gordon:
An inspection of your facility located at 217 S. Main Street, Hillsboro, North Dakota, was conducted by investigators from the Food and Drug Administration (FDA) on March 16, 17, and 19, 2009. This inspection verified that your firm manufactures and distributes food products, including various acidified food products.
As a manufacturer of acidified foods, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 114, Acidified Foods (21 CFR 114). The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and certain requirements of 21 CFR 114. In addition, based upon certain requirements in 21 CFR 114, acidified foods may be adulterated within the meaning of section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4) [21 U.S.C. § 342(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. Your firm's failure to fulfill certain requirements of 21 CFR 114 renders your (b)(4) brand BBQ Black Bean Salsa, (b)(4) brand Peach Corn Salsa, and (b)(4) brand (b)(4) Black Bean Salsa adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. You can find the Act and the Acidified Food regulations through links on FDA's home page at http://www.fda.gov.
Your significant violations of the acidified food regulations are as follows:
1. Your firm failed to maintain processing and production records showing adherence to the scheduled processes, including records of pH measurement and critical factors intended to ensure a safe product, in compliance with 21 CFR 114.100(b). Specifically, our investigator reviewed your records and found that, on one occasion, you failed to record the pH measurement of your (b)(4) Black Bean Salsa and that, on several occasions, you failed to record the critical factor of process hold time for your (b)(4) Black Bean Salsa, (b)(4) BBQ Black Bean Salsa, and (b)(4) Peach Corn Salsa.
2. Your firm failed to note all departures from the scheduled process having a possible bearing on public health or the safety of the foods, identify the affected portion of the products, and record these departures and make them the subject of a separate file (or log identifying the appropriate data) delineating them, the action taken to rectify them, and the disposition of the portion of the products involved, as required by 21 CFR 114.100(c). Specifically, our investigators noted several deviations from your scheduled processes for your (b)(4) Black Bean Salsa, (b)(4) BBQ Black Bean Salsa, and (b)(4) Peach Corn Salsa and that you did not have records of the disposition of the portion of these products involved.
3. Your firm failed to ensure that each container is marked with an identifying code specifying the establishment where the product was packed, the product contained therein, and the year, date, and period during which it was packed, in compliance with 21 CFR 114.80(b). Specifically, your acidified food products, including (b)(4) BBQ Black Bean Salsa, (b)(4) Peach Corn Salsa, and (b)(4) Black Bean Salsa, were not marked with an identifying code.
Current Good Manufacturing Practice:
Our investigators also found that you have a significant deviation from the current Good Manufacturing Practice (CGMP) regulations for foods, 21 CFR 110. This violation causes the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Specifically, your firm failed to maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in repair sufficient to prevent food from becoming adulterated, to comply with 21 CFR 110.35(a). Our investigators observed the exhaust fans directly over the (b)(4) cookers # 1 and 2 creating a down draft, rather than exhausting the steam created during processing. As a result, condensate was observed on the motor and angle iron motor support directly over (b)(4) cooker # 1. Droplets of condensation were observed dripping into your cheese sauce product.
Your Mexican Village Gravies (Red and Mexican) and Simply Great Blue Cheese Dressing products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:
• The label for your Mexican Village Mexican Gravy product (14 oz. size) fails to declare nutrition information, as required by 21 CFR 101.9(c), in a "Nutrition Facts" panel, as required by 21 CFR 101.9(d)(1).
• The labels for your Simply Great Blue Cheese Dressing and Mexican Village Red Gravy products are not formatted in accordance with 21 CFR 101.9.
o The "Nutrition Facts" panel does not include an "Amount Per Serving" subheading, as required by 21 CFR 101.9(d)(4).
o Several of the nutrients in the "Nutrition Facts" panel on the labels of these products are not rounded in accordance with 21 CFR 101.9(c).
• Both labels fail to express the number of calories and calories from saturated fat to the nearest 5-calorie increment, up to and including 50 calories, as required by 21 CFR 190.6(c)(1) and (c)(1)(iii). The label on your Red Gravy product also fails to express the number of calories from fat to the nearest 5-calorie increment, up to and including 50 calories, as required by 21 CFR 190.6(c)(1)(ii).
• Both labels fail to express the number of milligrams of sodium to the nearest 10-milligram increment when the serving contains greater than 140 milligrams, as required by 21 CFR 190.6(c)(4).
• The label on your blue cheese dressing product fails to express the number of grams of protein to the nearest gram, as required by 21 CFR 190.6(c)(7).
o The serving sizes on the "Nutrition Facts" panels are not expressed in common household measures appropriate to the food, as required by 21 CFR 101.9(b)(1). The serving size for these products must be expressed in cups, tablespoons, or teaspoons, as required by 21 CFR 101.9(b)(5)(i).
o The labels for these products do not include, after the serving size declaration, an equivalent metric quantity in parenthesis, as required by 21 CFR 101.9(b)(7).
Your Mexican Village Gravies (Red and Mexican) 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 labels fail to declare the common or usual name of each ingredient. For example, the labels for your Mexican Village Gravies (Red and Mexican) products declare Vegetable Oil; however, this is not a proper common or usual name of these ingredients [21 CFR 101.4(b)(14)]. Each individual fat and/or oil ingredient of a food intended for human consumption must be declared by its specific common or usual name (e.g. "beef fat," "cottonseed oil") in its order of predominance in the food, except that blends of fats and/or oils may be designated in their order of predominance in the foods as "__ shortening" or "blend of__oils," the blank to be filled in with the word "vegetable," "animal," "marine," with or without the terms "fat" or "oils," or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., "vegetable oil shortening (soybean and cottonseed oil) ."
We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates these corrections, if applicable. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
Failure to make prompt corrections may result in enforcement action, including seizure, injunction, and emergency permit actions being initiated by the FDA. This letter does not represent a comprehensive review of all of the products distributed by your firm. As president, it is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.
In addition to the violations discussed above, we also have the following comments regarding your labels:
During the inspection, our investigator documented that you use cheddar cheese in your Mexican Village Queso Dip as well as flour in your Mexican Village Gravies. Cheddar cheese contains milk, and flour contains wheat; both milk and wheat are major food allergens as defined in section 201(qq) of the Act [21 U.S.C. § 32l(qq)]. If your Queso Dip contains milk and your Gravy products contain wheat, the labels must indicate the presence of milk or wheat, as required by section 403(w) of the Act [21 U.S.C. § 343(w)]. You may find the Act through links in FDA's home page at http://www.fda.gov.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) amended the Act to require food labels to clearly disclose the food source of ingredients that are or contain a protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. Any food product labeled on or after January 1, 2006, must comply with FALCPA. Failure to comply with FALCPA causes a food to be misbranded under section 403(w) of the Act [21 U.S.C. § 343(w)]. A copy of FALCPA and other information regarding food allergens can be found on our website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
The labels for your Simply Great Blue Cheese Dressing and Mexican Village Red Gravy products do not contain information on trans fat content. The label must declare the number of grams of trans fat in a serving; if the serving contains less than 0.5 gram trans fat, the content must be expressed as zero, except when the statement, "Not a significant source of trans fat" is used, as required by 21 CFR
The ingredients Worcestershire sauce and mustard are declared as ingredients on the label of your Simply Great Blue Cheese Dressing. For multi-ingredient foods, sub-ingredients must be declared, as required by 21 CFR 101.4(b)(2). The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food (21 CFR 101.4(b)(2)].
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated in the letterhead. Ms. Wisecup may be reached at (612) 758-7114.
W. Charles Becoat