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WARNING LETTER

Remnant Inc. DBA The Donut Stop MARCS-CMS 544523 — Mar 19, 2018

Remnant Inc. DBA The Donut Stop - 544523 - 03/19/2018


Recipient:
Recipient Name
Randy H. Rodgers
Remnant Inc. DBA The Donut Stop

500 W. Sheridan Ave.

Shenandoah, IA 51601
United States

Issuing Office:
Kansas City District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Foods –
Division II West
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

 

March 19, 2018
 
WARNING LETTER
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
CMS Case # 544523
 
Randy H. Rodgers, Owner
Remnant Inc. DBA The Donut Stop
500 W. Sheridan Ave.
Shenandoah, IA 51601
 
Dear Mr. Rodgers:
 
The U.S. Food and Drug Administration (FDA) inspected your donut manufacturing facility located at 500 W. Sheridan Ave., Shenandoah, IA 51601, on December 4-6, 2017. During the inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 [21 CFR Part 110]. At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm's food products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [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 heath.
 
In addition, our investigator collected labels associated with some of the products you manufacture during the inspection of your facility. Based on our review, we have concluded that these products are in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and its implementing regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101).
 
You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov.
 
We acknowledge receipt of your correspondence on January 2, 2018 in which you provided a response to Form FDA-483, Inspectional Observations. Our comments concerning your response are noted below.
 
Your significant violations are as follows:
 
Adulterated Food
 
1.    Your firm failed to perform filling, assembling, packaging, and other operations in such a manner that protects food from becoming contaminated as required by 21 CFR 110.80(b)(13). Specifically, your firm manufactures products which contain wheat, egg, milk, soy, and nut products considered as major allergens. However, you have no allergen control program in place, such as scheduling production based on allergens, having dedicated equipment, or effectively cleaning between your products. Additionally, your firm did not take steps to prevent cross-contamination between raw and cooked donuts. Our investigator observed your firm topping finished product with nuts (an allergen) and immediately afterwards continue to frost finished product without washing hands or donning gloves. Our investigator also observed your firm working with raw dough and handling finished product without washing handing or donning gloves. Your employees were observed to touch hair face, glasses, and television remote during processing without hand washing.
 
To this date, your firm has not provided documentation that this observation is corrected.
 
2.    Your firm failed to maintain finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1). Specifically, your firm reuses visibly soiled cardboard containers to package finished donuts for delivery to wholesale customers. Allergen and non-allergen finished products are packed side by side in these boxes. Although plastic liners are used, they do not provide adequate barrier between the allergen containing finished product and non-allergenic containing product. Additionally, the cardboard boxes cannot be cleaned.
 
To this date, your firm has not provided documentation that this observation is corrected.
 
3.    Your firm failed to handle work-in process to protect it from contamination, as required by 21 CFR 110.80(b)(5). Specifically, the investigator observed uncovered dough being stored for further processing in the refrigerator in direct contact with the sides and back of the refrigerator where visible organic matter and debris was present.
 
To this date, your firm has not provided documentation that this observation is corrected.
 
4.    Your firm failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically, the investigator observed food debris and food residue on the sides and bottom of the proofer and raised uncooked donuts were directly touching the sides of the proofer; the belt on the dough sheeter that is used as a production line to add flavoring, shape and cut doughs was not cleaned or sanitized prior to production with visible flour build-up and residue; the dough cutter was not cleaned and sanitized prior to production and had build-up which appeared to be old dough; and the dough mixing bowl was observed being cleaned with a  untested (b)(4) solution and wiped with a rag, and the bowl still had visible residue subsequent the cleaning process. This is a repeat observation from previous state of Iowa, Department of Inspections and Appeals, inspections.
 
To this date, your firm has not provided documentation that this observation is corrected.
 
5.    Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). Specifically, during the inspection our investigator observed visible holes and flaking and peeling paint in multiple areas of the ceiling in the production facility including an area above where in-process dough was stored uncovered; the ceiling fan observed to be in use in the production was covered in food dust and residue; this fan is located above the proofer, fryer, icing/frosting area, and finished donut holding area; the interior walls  throughout the facility were observed to be visibly soiled with food dust; the wall behind the ingredient storage area and next to the refrigerator had become separated from the exterior wall creating an approximately 3-4 inch gap between the walls; the gap was observed to be stuffed with newspaper and ingredient bags; additionally the wall behind the finished product boxes and cake donut frosting area had also become separated from the structure of the facility with a visible gap for accumulation of debris. This is a repeat observation from previous state of Iowa, Department of Inspections and Appeals, inspections.
 
We acknowledge your January 2, 2018 response that stated your firm is planning to have a contractor repair the damaged walls in your kitchen, and it should be completed by mid-January, and your February 1, 2018 response that included pictures of what appears to be the installation of a new wall. However, there is no documentation submitted to confirm implementation of your corrective actions.
 
6.    Your firm failed to ensure all persons working in direct contact with food conform to hygienic practices while on duty to product against contamination of food by employees wearing suitable outer garments that protect against contamination of food as required by 21 CFR 110.10(b)(1). Specifically, the investigator observed employees using their bare forearms to transfer in- process dough from the dough sheeter to a wooden table for slicing and then onto the cracker cutting line. Additionally, personal belongings were observed in the production area in proximity to exposed food, such as tea, peanut butter, vitamins, and antacids.
 
To this date, your firm has not provided documentation that this observation is corrected.
 
Misbranded Food
 
1.    Your wholesale products, including but not limited to your cake donuts, apple fritters, and cinnamon rolls, are misbranded within the meaning of Section 403 of the the Act [21 U.S.C. § 343] because they are not labeled in accordance with 21 CFR Part 101. Specifically, the cardboard boxes you use to transport your wholesale products from your facility to your customers constitutes packaging and, therefore, must bear all mandatory labeling information. Your wholesale product labels are in violation of Section 403 of the Act because they do not include:
 
  A declaration of all major food allergens within a Contains statement or the ingredient list [Section 403(w) of the Act [21 U.S.C. 343(w)]]. We note that Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines a major food allergen as 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 certain exceptions, e.g. highly refined oils derived from a major food allergen. For example, your vanilla cake donut, which is used in some of your wholesale products, is manufactured using the ingredients wheat flour, soy flour, dry egg yolk, whey, wheat starch, and nonfat dry milk. These ingredients are or contain one or more major food allergens; however, you do not declare the presence of the major food allergens on your product label in accordance with Section 403(w) of the Act. Furthermore, if the remainder of your wholesale products are manufactured using ingredients, such as peanuts, soy flour, nonfat dry milk, egg yolk, wheat flour, and/or whey, that are or contain one or more major food allergens, your wholesale product labels must include a declaration of such, in accordance with Section 403(w) of the Act.
  The common or usual name of each ingredient, including all sub-ingredients (ingredients of an ingredient), as required by 21 CFR 101.4 [Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)]]. For example, your wholesale donuts are manufactured using multi- component ingredients; however, you fail to declare any ingredient information on your wholesale product packaging.
  A declaration of the presence of any artificial coloring, flavoring, or chemical preservative present and the function of any chemical preservative, as required by 21 CFR 101.22 [Section 403(k) of the Act [21 U.S.C. 343(k)]]. For example, some of your wholesale  cake donut products are manufactured using the ingredient (b)(4), which contains artificial colors that are not appropriately declared on your wholesale product packaging [21 CFR 101.22(k)(1)]. Furthermore, the following preservatives are used in the manufacture of your wholesale products; however, these preservatives and their functions are not declared in accordance with 21 CFR 101.22(j): sodium sulfite, benzoic acid, potassium sorbate, sodium benzoate, sodium erythorbate, sodium metabisulfite in apple filling; potassium sorbate, sorbic acid, and sulfites in icing mixes.
  The statement of identity of the food, as required by 21 CFR 101.3 [Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)]].
  Name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5. [Section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)]].
  A statement of the net quantity of contents, as required by 21 CFR 101.7 [Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)]].
 
2.    Your Glazed Donuts, Cinnamon Rolls, and Super products are misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] because they are not labeled in accordance with 21 CFR Part 101. Specifically, Your Glazed Donuts, Cinnamon Rolls, and Super product labels are in violation of Section 403 of the Act because they do not include:
 
  A declaration of all major food allergens within a Contains statement or the ingredient list [Section 403(w) of the Act [21 U.S.C. 343(w)]]. We note that Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines a major food allergen as 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 certain exceptions, e.g. highly refined oils derived from a major food allergen. Your Glazed Donuts, Cinnamon Rolls, and Super products are manufactured using ingredients that are or contain one or more major food allergens; however, you do not declare the presence of the major food allergens in accordance with Section 403(w) of the Act. Specifically, you fail to declare the major food allergens “wheat” and “soy” on your Glazed Donuts, Cinnamon Rolls, and Super products.
  The common or usual name of each ingredient, including all sub-ingredients (ingredients of an ingredient), as required by 21 CFR 101.4 [Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)]]. Your Glazed Donuts, Cinnamon Rolls, and Super product labels declare a statement of ingredients; however, your products are fabricated from multi-component ingredients and you fail to declare the sub-ingredients of these multi-component ingredients. For example:
 
o   Your Glazed Donuts, Cinnamon Rolls, and Super products are manufactured using the multi-component ingredient “(b)(4),” which is comprised of the sub-ingredients “enriched wheat flour bleached (flour, niacin, iron, thiamine mononitrate, riboflavin, folic acid), dextrose, soybean oil, salt, leavening (sodium acid pyrophosphate, baking soda), contains 2% or less of: beta-carotene (color), eggs, mono- and diglycerides, nonfat milk, sodium stearoyl lactylate, soy flour, whey.” These sub-ingredients are not all declared within the ingredient statement on your product labels.
o   Your Glazed Donuts, Cinnamon Rolls, and Super product labels declare the ingredient “veg. shortening;” however, you fail to declare the individual vegetable oils [21 CFR 101.4(b)(14)].
o   Your Glazed Donuts, Cinnamon Rolls, and Super product labels fail to declare the ingredients in the frostings or icings used for each product.
 
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component 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)].
 
  The statement of identity of the food, as required by 21 CFR 101.3 [Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)]]. Your Super product does not offer a statement of identity that is sufficiently specific to meet the requirements of 21 CFR 101.3.
  Place of business of the manufacturer, packer, or distributor, as required by 21 CFR
101.5 [Section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)]]. Your Glazed Donuts, Cinnamon Rolls, and Super products fail to provide the place of business with sufficient specificity, including the street address and zip code [21 CFR 101.5(d)]. We note that the street address may be omitted if it is shown in a current city directory or telephone directory.
  A statement of the net quantity of contents, as required by 21 CFR 101.7 [Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)]]. You do not provide this information on your Glazed Donuts, Cinnamon Rolls, and Super product labels.
 
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws.
 
You should take prompt action to correct the violations noted in this letter. Failure to do so may result  in regulatory action by FDA without further notice, including, without limitation, seizure and injunction. 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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection- related costs.
 
Within fifteen (15) working days of the receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved. If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.
 
Address your reply to the U.S. Food and Drug Administration; Attn: Victoria A. Wagoner, Compliance Officer, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions regarding any issue in this letter, please contact Victoria Wagoner, Compliance Officer at (913) 495-5150 or Victoria.Wagoner@fda.hhs.gov. 

 
Sincerely,
/S/
Cheryl A. Bigham Program Division Director
Office of Human and Animal Foods – Division II West
 
_________________________________
1    Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size.  See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.