Inspections, Compliance, Enforcement, and Criminal Investigations
Oskri Corp. 1/21/14
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) 334-4100
FAX: (612) 334-4142
1. You failed to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1). Specifically:
- During our inspection your firm was observed manufacturing products containing tree nuts (almonds, pecans, walnuts, and cashews), milk and soy in the same product area and on the same processing tables as products without tree nuts, milk and soy, including products labeled as “nut free” and “Lactose Free,” without cleaning and sanitizing between productions. For example, it was observed on May 23, 2013, that Cashew Cranberry Bars and Protein Cashew Bars were manufactured on the same processing table as Coconut Cherry Bars (i.e., that do not contain cashews) processed the previous day (i.e., May 22, 2013) without cleaning or sanitizing prior to use or sequencing products to prevent cross-contamination between the products that contain tree nuts, milk and soy, and those that do not. In addition, the investigator observed significant food debris on processing tables prior to placing the Coconut Cherry Bar batter onto the tables for rolling and cutting. When the investigator informed you of the condition of the tables, you directed an employee to clean the table. However, the investigator observed the employee cleaning the table by scraping the hard food particles off with a scraping tool and wiping the table with a damp paper towel, and no detergent or sanitizer was used to ensure proper cleaning and sanitizing;
- On May 23, 2013, leftover food debris from a previous production date was observed in a standing mixer paddle assembly, and dark liquid was dripping from the central assembly into the mixing bowl just prior to being used by employees to manufacture sesame bars. The bowl and assembly were not cleaned or sanitized prior to use;
- On May 22, 2013, a vertical-filler was used to package Cashew Cranberry Crunch and afterwards the stainless steel scales and bucket elevator cups were removed for cleaning. However, on May 23, 2013, significant residue from this product was observed remaining in and around food-contact surfaces of the filler equipment. The buckets and scales were reassembled for use without proper cleaning or sanitizing of the filler itself;
- Food utensils and cutting equipment, stored on a metal rack labeled “clean,” were observed with visible food residue after being washed on May 22, 2013.
2. You failed to take effective measures to protect against the inclusion of metal or other extraneous material in food, as required by 21 CFR 110.80(b)(8). Specifically:
- You do not have any systems in place to protect against inclusion of metal in your products. Review of your complaint records revealed that you have received multiple consumer complaints involving metal shavings/pieces. Your firm determined that the metal shavings originated from copper mixing bowls that had been used for approximately three years until their removal on May 20, 2013. These bowls were used to manufacture at least six known varieties of sesame bars and possibly other bars. Despite consumer complaints on metal fragments for multiple lots of products, you only recalled one lot of product (lot 84 manufactured on March 29, 2013);
- Your copper mixing paddles were damaged and yet were observed to be still in use;
- The bars were cut either with automated equipment or by hand with thin stainless steel blades. No programs were in place to protect the products against contamination of possible metal fragments from damaged or broken cutting blades;
- Review of your complaint records revealed that you did not investigate a consumer complaint regarding glass inclusion in your product.
3. You failed to perform assembling and packaging in such a way as to protect food against contamination, as required by 21 CFR 110.80(b)(13). Specifically, while rolling and flattening Cashew Cranberry Bars with rolling pins during production, employees were observed leaning over the bars while wearing smocks which appeared soiled and unclean. These smocks were in direct contact with the bars. In addition, the rolling pins were observed with visible pitting prior to, and after, use.
4. You failed to provide appropriate training in proper food handling techniques and food protection principles, and to inform employees of the danger of poor personal hygiene and insanitary practices, as required by 21 CFR 110.10(c). Specifically, employees at your facility who directly handle food items have not been effectively trained in safe food handling sanitation, or prevention of cross-contact from allergens. Our investigator interviewed employees and they were unaware of any training programs that had been implemented and were unable to identify training provided for proper cleaning and sanitation practices. In addition, our investigator also interviewed the Production Managers who are responsible for overseeing production operations and employees, and they were not aware of any procedures used to reduce cross-contact of allergens.
5. You failed to hold bulk raw material and ingredients in suitable containers so as to prevent against contamination, as required by 21 CFR 110.80(a)(5). Specifically, roasted and unroasted nuts and seeds are stored in bulk metal bins with metal mesh screen lids. The lids do not fully cover the ingredients, nor do they protect from adulterants or contaminants. For example, on May 23, 2013, a bulk bin of cashews and a bulk bin of sesame seeds had drips of clear and dark liquid drops on the mesh screens. Also, the bins were not labeled with the ingredient name or lot information.
6. You failed to operate fans in a manner that minimized the potential for contaminating food and food-contact surfaces, as required by 21 CFR 110.20(b)(6). Specifically:
- Two fans are installed on the sesame press conveyor and were observed to blow cool air directly onto sesame bars as they move through a series of cutting and pressing equipment. Significant debris, dirt, and dust accumulation was observed inside the fans which may be a source of contamination;
- Two large, standing fans were being used to cool the production room. The fans were blowing air directly onto stacked, uncovered sesame bars awaiting packaging; the grates of the fans had debris, dirt and dust accumulation.
7. You failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically:
- On May 22, 2013, an insect electrocution trap was installed in the nut roasting room directly above where uncovered tree nuts are cooled on racks;
- Pest control boxes were out of place during production and ineffective for their use in the bar production area.
8. Your Coconut Bar Mango is adulterated within the meaning of section 402(c) of the Act, 21 U.S.C. § 342(c), because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act, 21 U.S.C. § 379e(a). Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use, 21 CFR 74.705(d)(2). The Coconut Bar Mango product is manufactured with dehydrated sweet diced mangos, which contains FD&C Yellow No. 5; however, the labels for these products fail to declare the presence of FD&C Yellow No. 5 in the ingredient statements.
9. Your Oskri snack bar products are misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because the products bear or contain an artificial flavoring, coloring, or chemical preservative, but fail to bear labeling stating that fact. For example:
- Your Apricot Almond Bar, Cashew Peach Bar, Apricot Bar, Peach Bar, Coconut Bar Mango and Peach Granola products contain sub-ingredients that are not declared on the finished product label in accordance with 21 CFR 101.4(b)(2). Specifically, the Dried Peaches ingredient label states “Peaches, Sulfur Dioxide, and Rice Flour (sulfur Dioxide added to promote color retention).” Sulfur dioxide is not listed as an ingredient or sub-ingredient. A food to which a chemical preservative(s) is added shall, except when exempt pursuant to 21 CFR 101.100 bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor” or “to promote color retention” in accordance with 21 CFR 101.22(j);
- In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Your Coconut Bar Mango product is manufactured with dehydrated sweet diced mangos containing certified color additives FD&C Yellow No. 5 and FD&C Yellow No. 6; however, neither product bears a label identifying the presence of these color additives. Under 21 CFR 101.22(k)(l), certified colors must be declared by the name of the color additive listed in the applicable regulation in Part 74 or Part 82 of this chapter. The common or usual name may be abbreviated to omit the “FD&C” prefix and the term “No.” (e.g., Yellow 5).
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines as “major food allergens” 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. A food is misbranded 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 ingredient, 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., “(wheat),” 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).
- You failed to declare the number of servings per container on your 5-bar and 20-bar packages in accordance with 21 CFR 101.9(b)(8)(iv);
- Your Coconut Bar Mango and Protein Bar Cashew Cranberry individual bar labels do not declare Calories from Fat in accordance with 21 CFR 101.9(c)(1)(ii);
- All of your labels and labeling declare the gram amount for protein on the principal display panel. However, the Percent Daily Value for protein is not declared in the nutrition label as required in 21 CFR 101.9(c)(7)(i) when a nutrient content claim is made for protein. Declaring the gram amount of a nutrient anywhere other than in the nutrition label is a nutrient content claim and all applicable parts of the Act, 21 CFR 101.9, and 101.13 must be followed unless specific exemptions are provided;
- Your Coconut Cherry Bar individual bar label declares the amount for sodium as 32mg but declares 0% for the Percent Daily Value, and Dietary fiber is declared as 3.8g but the Percent Daily Value is not declared in accordance with 21 CFR 101.9(d)(7)(ii). In addition, the label includes a milligram amount for iron which is not provided for in 21 CFR 101.9(c)(8);
- Your Coconut Dark Chocolate Bar, Cashew Peaches Bar, Sesame Bar with Date Syrup and Black Cumin, Coconut Bar Mango and Protein Bar Cashew and Cranberry labels include information, such as allergen information and/or the statement “For United States Only,” within the nutrition label which is not provided for within 21 CFR 101.9(d).
- The primary label of the Sesame Bar with Date Syrup and the multipack label lists 9% iron vs. the display product label listing of 90% iron;
- The primary label of the Sesame Bar with Date Syrup and Fennel lists 9% iron and the multipack carton lists 18.6% iron;
- We question whether your “Protein Bar Cashew Cranberry” is an appropriate statement of identity for this product in accordance with 21 CFR 101.3. Based on the ingredient list, a protein ingredient is not the predominant ingredient.