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WARNING LETTER

Hannibal Company Inc MARCS-CMS 487506 — May 12, 2016

Hannibal Company Inc - 487506 - 05/12/2016


Recipient:
Hannibal Company Inc


United States

Issuing Office:
Cincinnati District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

 

Via United Parcel Services
 
May 12, 2016
 
Mr. Carl W. Caulkins, President/General Manager
Hannibal Company Inc.
6530 Proprietors Road
Worthington, OH 43085-3233
 
Warning Letter
CIN-16-487506-13
 
Dear Mr. Caulkins:
 
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 6530 Proprietors Road, Washington, Ohio on October 2, 7, 9, 14, and 15, 2015 and November 2 and 3, 2015. The inspection found significant deviations from FDA’s regulations for Current Good Manufacturing Practice (CGMP) in the manufacturing, packing or holding of human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These deviations cause the foods manufactured at your facility 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. 
 
Furthermore, our investigator collected labels of your products. Based on our review, we have determined that your unlabeled 9 inch sub buns are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and the applicable regulations in Title 21, CFR, Part 101. You may find the Act and FDA regulations on the internet through links on the FDA webpage at www.fda.gov.
 
Our inspection of your facility revealed the following deviations:
 
Adulteration Violations
 
1.    Your firm failed to implement 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,
 
a.    Houseflies were observed walking on the egg knot dough, the dough mixer and on the baking pans covered with parchment paper.
b.    Houseflies, too numerous to count, were observed flying around the manufacturing facility.
c.    Dead houseflies too numerous to count were stuck on ten sticky flytraps hanging from the ceiling in the manufacturing area. 
d.    Approximately 56 dead insects were in the light shield directly above the divider near the proofing room.
 
2.    You failed to take all reasonable measures and precautions to ensure that all persons working in direct contact with food, food contact surfaces and food packaging material, shall conform to hygienic practices while on duty to the extent necessary to prevent the contamination of food, including washing hands thoroughly when hands may have become soiled or contaminated, to comply with 21 CFR 110.10(b)(3). However, the following was observed:
 
a.    An employee was observed touching a broom and then placed parchment paper onto baking pans with her bare hands.
b.    Two employees were observed washing their hands for two to three seconds prior to manufacturing egg knot dough. 
 
3.    You must take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, to comply with 21 CFR 110.80. However, the following conditions were observed:
 
a.    Employees failed to clean shared equipment after manufacturing egg knots made with eggs prior to manufacturing buns made without eggs.
b.    Condensate was observed dripping from humidifiers in proofing room above uncovered hamburger buns. 
c.    Employees were observed retrieving a mop, bucket and garbage can that were stored outside, bringing them into the manufacturing areas for use and then storing them back outside.
d.    An employee was observed retrieving approximately 10 empty plastic bread trays from the outside storage area and proceeded to place packaged bread onto the trays without washing or sanitizing them.  
e.    A number of insanitary conditions were observed in your manufacturing facility, including standing water on the floor, a mold-like substance growing on the proofing room walls, corroded aluminum baking pans were observed in use, mold-like substance growing on steam vents that blow directly on in-process bread products, processing aprons stored with employee items, an excessive amount of trash stored within four inches of raw in-process materials, and plastic wrap used to wrap bread racks is stored directly on processing room floor.
f.    Diluted bleach was observed in a container labeled as “LA’s Totally Awesome” and egg wash was in a container labeled as Bavarian Crème, and “Dyno Max”, a bread sub-ingredient, was stored directly on the floor without a lid. 
 
4.    Supervisory personnel are not competent in current good manufacturing practices to assure personnel are in compliance with all requirements to comply with 21 CFR 110.10(d). Specifically, the president of the firm admitted that the firm does not have any formal training. Additionally, he stated neither he nor the supervisors have been trained in cGMP practices. He is also unaware of allergen hazards, good employee hygiene, preventing pest activity and proper use of a 3-compartment sink.
 
5.    Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigator observed the following potential pest ingress routes:
 
a.    Three approximately 1’ gaps were observed under a garage-style delivery door.
b.    Several window screens throughout the facility were observed to have three inch by quarter inch gaps. 
c.    An extension cord was observed extended through an open window on the south wall in the food storage area, allowing for a 3” x 2” opening. 
d.    An opened and unscreened door was approximately two feet away from the manufacturing and cooling of brioche bread. Additionally, an approximate 2 foot gap in length opening in a door was next to the same cooling brioche bread. 
 
6.    Your firm 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,
 
a.    Baking pans were only washed with detergent and not sanitized during the entire inspection. Additionally, pans were also observed to be reused without being cleaned. 
b.    An employee was observed washing a corroded pan with her bare-hands. 
c.    After the evening clean-up, but prior to production activities, the mixer and divider were observed with bread debris and tiny black specs. 
d.    The third compartment of the three compartment sink was not being used properly as it was covered and coated with a white mold-like substance and food debris. 
 
7.    Your firm failed to properly store equipment, remove litter and waste, or cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests within the immediate vicinity of the plant buildings or structures as required by 21 CFR 110.20(a)(1). Specifically, investigators observed plastic bread trays stored along the north and east walls outside of the building. This area also contained weeds, bushes, shrubs, a bird’s nest, a filled gasoline can and other miscellaneous equipment.   
 
8.    Your firm failed to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food as required by 21 CFR 110.20(b)(1). Specifically,
 
a.    Plastic bread trays are routinely stored outside of the facility.
b.    On October 7, the mop closet was completely blocked by bread in the food storage area. 
c.    The mop and mop bucket was observed stored outside of the facility on three days of the inspection. Three brooms were also observed stored outside of the facility.
 
9.    Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-contact surfaces, and food packaging materials, as required by 21 CFR 110.20(b)(6). Specifically, our investigator observed four fans covered with dust where food was exposed in the production areas. Two of the fans were in a window blowing in outside air with one fan being approximately two feet from a mixing bowl. The other two hanging fans with apparent dust particles, used to expedite the cooling process were blowing directly on the bread.   
 
10.    Your firm failed to properly maintain plant equipment as to be adequately cleaned and properly maintained, as required by 21 CFR 110.40(a). Specifically,
 
a.    Employees were observed using corroded baking pans during manufacturing.
b.    Conveyor belts on the firm’s divider that are food contact surfaces are frayed and in poor repair. 
c.    The metal mixing arm of the (b)(4) mixer is chipped. 
d.    The wooden table in the packaging area is scratched and pitted. 
e.    A Wagoner brand power sprayer labeled for household use only was used to spray egg wash on various bread buns. 
 
11.    Your hand washing facility in your manufacturing area lacked running water at a suitable temperature as required by 21 CFR 110.37. Specifically, your only hand washing sink in your manufacturing area did not have hot water available. Additionally, this hand washing station was without soap and hand towels.
 
12.    Your firm failed to properly store toxic chemicals in a manner that protects against contamination of food products, as required by 21 CFR 110.35(b)(2). Specifically, Pine Sol cleaner was stored atop a sub-ingredient box and approximately two feet away from uncovered container of salad oil used to manufacture your egg knot rolls.    
 
13.    Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). Specifically, our investigator observed the following insanitary conditions:
 
a.    Old dough and bread, covered in cobwebs and other debris was observed under the pallet under the firm’s divider. 
b.    The walls in the manufacturing area were discolored and appeared insanitary and unclean.
 
14.    Your firm failed to require personnel to wear hair restraints where appropriate, as required by 21 CFR 110.10(b)(6). Specifically, multiple employees were observed wearing hairnets incorrectly with exposed hair and braids protruding from the hairnets, while manufacturing food products. 
 
15.    Your firm failed to construct your facility in such a manner that floors, walls and ceiling may be adequately cleaned and kept clean and kept in good repair, as required by 21 CFR 110.20(b)(4). Specifically,
 
a.    The proofing room ceiling is made of loosely hanging plastic that have several holes.
b.    The manufacturing area ceiling is not smooth and easily cleanable. Additionally, two ceiling tiles are missing. 
c.    The floors in the manufacturing area had peeling paint, exposed concrete and not easily cleanable. 
 
16.    Your firm failed to ensure personnel remove all unsecured jewelry and other objects that might fall into food, equipment or containers and remove hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean and sanitary condition and which effectively protects against the contamination by these objects of the food, food contact surfaces, or food packaging materials as required by 21 CFR 110.10(b)(4). Specifically,
 
a.    An employee was observed wearing earrings and a necklace while manufacturing nine inch submarine buns.
b.    An employee was observed wearing earrings while manufacturing four inch hamburger buns.
c.    An employee was observed wearing earrings, a necklace and bracelet while manufacturing egg knot rolls. 
 
17.    Your firm failed to remove personal belongings that are stored in an area where food is exposed a required by 21 CFR 110.10(b)(7). Specifically,
 
a.    Employee beverages are stored in the firm’s refrigerator in the manufacturing area that also contained eggs, butter and cheese used during manufacturing.
b.    Several bags of cheddar cheese used in the manufacturing of egg knot rolls are stored in the employee break room refrigerator along with employee lunches and personal beverages. 
 
18.    Your toilet facilities lack self-closing doors as required by 21 CFR 110.37(d)(3). The men’s bathroom door was open for three days of the inspection approximately 6 feet away from finished product. 
 
19.    Your firm failed to provide readily understandable signs directing employees on handling unprotected food, unprotected food-packaging materials, food contact surfaces to wash and where appropriate sanitize their hands before they start work, after each absence from post of duty and when their hands may have become soiled or contaminated as required by 21 CFR 110.37(e)(5). Specifically, you have two non-English speaking employees, but you only have signs directing employees to wash their hands in English. 
 
Misbranding Violations
 
1.    Your unlabeled 9 inch sub buns, packaged in clear unlabeled plastic bags are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all major food allergens present in the products, such as wheat, 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 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 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 (e.g., “flour (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)]. 
2.    Your unlabeled 9 inch sub buns, packaged in clear unlabeled plastic bags 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 and the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4.
 
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. 
 
3.    Your unlabeled 9 inch sub buns, packaged in clear unlabeled plastic bags are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because there is no statement of identity on the Principal Display Panel, as required under 21 CFR 101.3.
 
4.    Your unlabeled 9 inch sub buns, packaged in clear unlabeled plastic bags are misbranded within the meaning of Section 403(e)(1) [21 U.S.C. § 343(e)(1)] in that the packages do not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
5.    Your unlabeled 9 inch sub buns, packaged in clear unlabeled plastic bags are misbranded within the meaning of Section 403(e)(2) [21 U.S.C. § 343(e)(2)] in that the outer containers for your products do not provide the net quantity of contents, as required under 21 CFR 101.105.
 
(b)(4) 
 
We also offer the following comments:
  • Your handmade Knotted Egg Rolls and handmade Knotted Egg Rolls Cheddar cheese declares soy lecithin as an ingredient in your ingredients statement, however you failed to declare soy in the “Contains” statement used on the food labels.  Since a “Contains” statement is used on the labels, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food.
  • We note that the ingredients for the Handmade Knotted Egg Rolls and Handmade Knotted Egg Rolls with Cheddar Cheese must be accurately declared. In an affidavit collected during the inspection states that the Conagra Mills King Midas Special flour is used to make all bread, rolls, and buns from 10/4-9/15. Although the ingredient list of the flour is not clear, it does not appear to be enriched. However, the ingredient list for the Handmade Knotted Egg Rolls and Handmade Knotted Egg Rolls with Cheddar Cheese declares enriched flour.  If enriched flour is not used in the manufacture of this product, the ingredient list is incorrect.  Furthermore, the nutrition information may also be incorrect.
  • We note that while your Egg Roll Skins and Wonton Skins products are sold primarily for further use or distribution, there are occasions when they are sold directly to the consumer. When these products are sold directly to the consumer, the products must bear the nutrition information required by 21 CFR 101.9, unless an exemption applies.
  • Regarding your Egg Roll Skins, Egg Noodles, and Wonton Skin product labels, the net quantity of contents should be declared in terms of weight designated in metric terms in addition to U.S. Customary terms (P.L. 102-329, August 3, 1992; 21 CFR 101.105).
  • The ingredients used in your products must be declared by descending order of predominance by weight as required by 21 CFR 101.4(a)(1). Based on the formulation provided by your firm, the soybean oil should be declared before the egg in the ingredient list. The formulation includes 9 lbs. of oil and 5 lbs. of eggs. 
Section 740 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. 
 
We request that you notify this office within 30 days of receipt of this letter with the actions you will take in response to this letter. Please send your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237, Attention: Allison Hunter. If you have any questions about this letter, please contact Compliance Officer Hunter at (513) 679-2700 ext. 2134 or by email at allison.hunter@fda.hhs.gov.
 
Sincerely,
/S/
Steven B. Barber
District Director
Cincinnati District
  
CC:     
Food Safety Division Chief
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399

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