- Casey's Bakery, Inc
- Issuing Office:
- Kansas City District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Southwest Region|
Kansas City District
8050 Marshall Drive
Lenexa, Kansas 66214-1524
March 22, 2016
SENT VIA UPS
Ref. CMS# 486909
Ronald L. De Groot, President/Owner
Casey's Bakery, Inc.
251 N. Main Ave., Suite 301
Sioux Center, IA 51250
Dear Mr. R.L. De Groot,
The U.S. Food and Drug Administration conducted an inspection at your manufacturing facility located at 251 N. Main Ave, Suite 301, Sioux Center, IA 51250 on November 3, 4, 5, 12, and 13, 2015. The inspection found significant violation of the FDA's Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CF Part 110). These violations cause the foods manufactured at your facilities to be 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 were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA's home page www.fda.gov
To date, we have not received a written response to the Form FDA 483, List of Inspectional Observations that was issued.
1. Your firm failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as necessary, in accordance with 21 CFR 110.80(b)(1). Specifically, your firm's dough sheeter, used during the production of doughnut dough and pastry dough for Almond Patties product, was observed to have visible product residue remains on the machine while not in use. Your firm's dry clean sweeping and (b)(4) does not appear effective in removing product from the dough sheet between runs. Poor sanitation and equipment maintenance may lead to cross contamination of allergens.
2. Your firm failed to manufacture food under such condition and controls as to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). Specifically, uncovered raw hamburger buns were being stored in the Proof Box, directly below condensation dripping from the ceiling of the Proof Box.
3. Your firm failed to properly maintain all equipment, as required by 21 CFR 110.40(a).
• (b)(4) mixers in the Production Room and Bakery were observed to have chipping paint over the mixing bowls.
• The production room wooden butcher block tables were observed to be in disrepair in a manner which would not ensure adequate cleaning and sanitation.
4. Your firm failed to maintain gloves, used in food handling of finished food products, in an intact, clean, and in sanitary condition, as required by 21 CFR 110.10(b)(5). Specifically, an employee was observed with gloved hands touching finished food product (Almond Patties product), then non-food contact surfaces, including the cabinets (cleaned (b)(4)) and the trash cans, during the operations, and then returning to production and handling finished food products without changing gloves.
5. Your firm failed to identify, hold, and store toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(b)(2). Specifically you had several unlabeled spray bottles located in your Production Room and Cleaning Storage Cabinet, which apparently contained water, a sanitizer solution, and mineral oil.
6. Your firm failed to assure your sanitizing agents were safe and adequate under the conditions of use, as required by 21 CFR 110.35(b)(1). Specifically, you were using a quaternary sanitizer to sanitize the butcher block tables, which were found to contain cuts, dents and in disrepair. The label of the quaternary sanitizer indicated the product should be used on hard non-porous, inanimate surfaces. Also, you were testing the quaternary sanitizer using expired test strips.
In addition, we reviewed your product labels and find that your labels cause your products to be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulation under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
1. Your "Turnovers" product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen; "milk" as required by section 403(w)(1) of the Act.
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. 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 is 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, 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, according to your recipe, your "Turnovers" product is manufactured using "butter blend" which contains "milk" however, you fail to declare "milk" on your finished product label.
2. Your "8x8 Snickers Cake" and "Turnovers" products are misbranded within the meaning of section 403(e)(2) of the Act, [21 U.S.C. § 343(e)(2)], in that the finished product labels fail to declare an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, as required by 21 CFR 101.105. Under 21 CFR 101.105(c), when the declaration of quantity of contents by numerical count does not give adequate information as to the quantity of food in the package, it shall be combined with such a statement of weight, measure, or size of the individual units of the foods which will provide such information. Count is not sufficient because the weight can vary. The net quantity of contents must include the net weight.
3. Your "Almond Patties" product is misbranded within the meaning of section 403(e)(1) of the Act, [21 U.S.C. § 343(e)(1)], in that the finished product label failed to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).
4. Your "8x8 Snickers Cake" and "Turnovers" products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. For example,
• Your "8x8 Snickers Cake" product label declares "enriched wheat flour" in the ingredient statement; however, it also declares potassium bromate as a sub-ingredient. Enriched wheat flour is a standardized food under 21 CFR 137.165 to which potassium bromate cannot be added.
• Your "Turnovers" product label declares "wheat flour" in the ingredient statement; however, "wheat flour" cannot contain the sub-ingredients declared.
• Your "Turnovers" product is manufactured butter blend margarine, icing, and apple filling; however, you fail to list all the sub-ingredients on your finished product labels.
According to 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.
5. Your "Almond Patties" product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label is missing nutrition information as required by 21 CFR 101.9. For example, the product label fails to declare a serving size in a common household measure as required by 21 CFR 101.9(b)(7).
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You should take prompt action to correct the violations described above and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, including but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
We also offer the following comments about your products labels:
• On the revised "Almond Patties" ingredient sticker, milk is declared as a sub-ingredient of the butter ingredient. If the milk is declared as the common or usual name of the allergen in accordance with FALCPA rather than as a sub-ingredient, then "milk" should be declared in separate parentheses following the butter ingredient declaration.
• You stated that butter is used in place of the ingredient listed as "margarine." We note that the ingredients list must accurately declare the ingredients used in the manufacture of the products. If margarine is not used, it should be removed from the label.
• Nutrition Facts labels are required for products that are not sold onsite.
• The use of any artificial colors must be declared in the ingredients statement.
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 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 there-inspection and assessing and collecting there-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.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. 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, 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 Andrew A. Hoopes, Compliance Officer at 210 Walnut St., Suite 369, Des Moines, IA 50309. If you have any questions about this letter, please contact Mr. Hoopes at 515-244-0480 ext 1002 or email him at email@example.com
Cheryl A. Bigham
Kansas City District