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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Oskri Corp. 1/21/14

  

Department of Health and Human Services logoDepartment 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) 334-4100
FAX: (612) 334-4142 

 

 
 
January 21, 2014
 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                            
 
Refer to MIN 14 - 07
 
 
Fekri Zainoba
President/Owner
Oskri Corporation
528 E. Tyranena Park Road
Lake Mills, Wisconsin 53551
 
Dear Mr. Zainoba:
 
On May 22, 23, 29, 31 and June 17, and 19, 2013, the U.S. Food and Drug Administration (FDA) conducted an inspection of your snack food manufacturing facility located at 528 E. Tyranena Park Road in Lake Mills, Wisconsin. During the inspection the FDA investigator documented serious violations of the Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. 
 
In addition, FDA conducted a review of your labeling for several of your products and found your Coconut Bar Mango product is adulterated within the meaning of section 402(c) and your Oski Snack Bar products are misbranded within the meaning of section 403 of the Act, 21 U.S.C. § 343, and the regulations for food labeling at 21 CFR 101. 
 
You can find the Act and its implementing regulations on the Internet through links on FDA’s home page at www.fda.gov.  
 
Current Good Manufacturing Practices
 

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.
 
Your response indicates that you will check all ingredients on all products and manufacture all allergen products one day of the week and non-allergen products the rest of the week, and you provided evidence of chemical training on June 14, 2013. However, your response is inadequate in that you have not provided clear evidence of correction; you have not provided information on product sequencing based on the different types of allergens present in your various products, or a detailed sanitation program demonstrating adequate cleaning and sanitizing to avoid allergen cross-contact.
 

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.
 
Your response indicates you have started to check the utensils during each shift.  Your response is inadequate in that you have not addressed effective measures to protect against the inclusion of metal or other extraneous materials in food, and you have not provided evidence of corrective action.
 

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.

 
Your response indicates you have provided Good Manufacturing Practice (GMP) training. However, documentation attached to your response does not specify what was considered during your GMP training. Therefore, your response is inadequate in that you have not provided evidence of corrective action.
 

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.

 
Your response is inadequate because it indicates you have not implemented appropriate training in food handling and food protection principles.
 

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.

 
Your response is inadequate because you have not provided corrective actions on how your firm intends to cover the ingredients stored in the bins to protect the ingredients against contamination.
 

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.
 
Your response is inadequate because you failed to provide corrective actions such as adopting and implementing a cleaning standard operating procedure.
 

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.
 
Your response is inadequate in that you only described that you will move the electrocution traps away from the production areas, but failed to provide information on where you would place the traps. In addition, you have not taken corrective actions regarding the ineffective placement of pest control boxes in the bar production area.
 
Labeling
 

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).
 
10.  Your Oskri snack bar products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the labels for these products fail to declare the known major food allergen, milk, as specified by the Act. 
 

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).
 
Specifically, the dark chocolate used to coat your Coconut Dark Chocolate Bar, Fig Dark Chocolate Bar and Almond Dark Chocolate Bar contains a milk ingredient, “butterfat (milk),” that is not declared on the product label. 
 
11.    Your Sesame Bar with Date Syrup and Black Cumin product is misbranded within the meaning of section 403(r)(1)(A) of the Act, 21 U.S.C. § 343(r)(1)(A), because the labeling bears a nutrient content claim, but does not meet the requirements to make the claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient, misbrands the product under section 403(r)(1)(A) of the Act. 
 
Specifically, the nutrient content claim “High In: Fiber* Iron* Calcium* Protein*” is not an approved claim in accordance with 21 CFR 101.54(b). The terms “high,” “rich in,” or “excellent source of” may be used on the label and in the labeling of foods, except meal products as defined in 101.13(l) and main dish products as defined in 101.13(m), provided that the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed. Based on our review, the values listed in the Nutrition Facts panel for one serving are 0.53g (2%) dietary fiber, 90% iron (identified as an error by Ms. Needham, Director of Sales and Marketing), 2% calcium, and 2.7g protein. The use of “High In” requires at least 20% of the daily value, which would be 5g fiber, 10g protein and 20% of calcium and iron. As labeled, your Sesame Bar with Date Syrup and Black Cumin does not meet these requirements in a serving size of one bar.
 
12.    Your Coconut Dark Chocolate Bar, Fig Dark Chocolate Bar, Almond Dark Chocolate Bar, Apricot Almond Bar, Protein Bar Cashew and Cranberry Bar, Cashew Peach Bar and Apricot Bar are misbranded within the meaning of section 403(f) of the Act, 21 U.S.C. § 343(f), because your product labels contain information in several languages but do not repeat all the required label information in those different languages. In accordance with 21 CFR 101.15(c)(2) and (3), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. We also point out that displaying nutrition information in another country’s format is not permitted.
 
13.    Your Oskri snack bar products are misbranded within the meaning of section 403(q) of the Act, 21 U.S.C. § 343(q), because the nutrition facts information is not displayed in accordance with 21 CFR 101.9. For example: 
 
  • 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).
 
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.
 
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
 
We also have the following comments about your labels:
 
  • 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.
 
Further, section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Please notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Your written response should be sent to Demetria Lueneburg, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Ms. Lueneburg at (612) 758-7210.
 
Sincerely,
 /S/ 
Michael Dutcher, DVM
Director
Minneapolis District