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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Bakery Project 9/5/13

  

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

Public Health Service
Food and Drug Administration
 
Kansas City District
Southwest Region
8050 Marshall Dr., Suite 205
Lenexa, Kansas 66214
 
Telephone:    (913) 495-5100

 

September 5, 2013
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
Ref. 2013-17
 
Kelly L. Dumford, Owner/President
Bakery Project, Inc.
1025 W. 29th St. N
Wichita, Kansas 67204
 
 
Dear Ms. Dumford:
 
The Kansas Department of Agriculture (KDA), under contract on the behalf of the United States Food and Drug Administration (FDA), inspected your manufacturing facility located at 1025 W. 29th St. N, Wichita, Kansas 67204 on July 31-August 1, 2013. The inspector found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations 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. You can find the Act and its implementing regulations on FDA’s home page www.fda.gov.
 
KDA’s inspection of your facility on July 31-August 1, 2013 revealed the following significant CGMP violations:
 
1.    You failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests as required by 21 CFR 110.35(c). Specifically, the inspector observed the following as evidence of pest infestation:
 
o   Approximately ten apparent flies on dough on the dough table,
o   Two, live apparent beetles on the hoagie machine below the rollers,
o   Ten, live apparent beetles and apparent larvae under plastic sheeting on the rack behind the small ingredient table,
o   Two, dead apparent beetles along the cloth belt on the loaf machine,
o   Six, live apparent flies on the food contact surface of the divider/rounder mat,
o   One, live apparent roach on the glue board under the three compartment sink on the west wall,
o   The glue board under the three compartment sink on the west wall covered with dead apparent roaches,
o   Apparent insect tracking on the non-food contact surface of sheeter machine, hoagie machine, loaf machine, on the rack behind the small ingredient table, and in an unused mixer bowl,
o   Eight, dead apparent roaches on the glue board on the west wall behind the oven, and
o   Insect webbing under the small ingredient metal table, between ovens, on the wall behind the ovens, on the underside of the large mixer above the bowl, on the loaf machine by the rollers, on the sheeter, under the work table in the artisan bread area, and in the corners of the windows.
 
2.    Your ceilings are not constructed in such a manner that they may be adequately kept in good repair, as required by 21 CFR 110.20(b)(4). Specifically, the inspector observed two separate holes in the ceiling leaking water onto the floor below. One, of which, was leaking water onto packaged product, steak buns.
 
3.    You failed to clean all food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d). Specifically, the inspector observed the following conditions:
 
o   Buildup of dried food debris on food contact surface of scale pan, measuring cups, and divider,
o   Buildup of flour and old dough on the underside of the mixer and large mixer, and
o   Buildup of old dough on the cotton belts on the loaf machine, sheeter machine, and hoagie machine.
 
4.    You failed to provide, where necessary, adequate screening or other appropriate protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the inspector observed the following:
 
o   A hole in the screen on the front screen door, used alone without a solid door upon arrival,
o   A large hole in the screen of the screen door in the oven room, used occasionally without a solid door per the firm’s person in charge, and
o   Two holes in the walls on the west side of the building without screening, one used with a fan for ventilation and one at the furnace where the gas line comes into the building. 
 
5.    You failed to have equipment and utensils so designed and of such material and workmanship as to be adequately cleanable, and properly maintained as required by 21 CFR 110.40(a). Specifically, the inspector observed the cracked food contact surface of the lid of the dough container.
 
6.    You failed to clean as frequently as necessary non-food contact surfaces of equipment used in operation of food plants to protect against contamination of food as required by 21 CFR 110.35(d)(3). Specifically, the inspector observed the following:
 
o   Buildup of old flour, old oil spray, flour mixed with oil on non-food contact surfaces of production tables, sides, legs, and shelving,
o   Buildup of old dough/flour on the metal wire guard on large mixer,
o   Buildup of old ingredients in the bottom of the ingredient bins where bags of ingredients in use are stored,
o   Buildup of filth on the timer on the ingredient bin,
o   Buildup of filth on the handles of a bucket on the small ingredient table,
o   Buildup of flour and/or dough on the non-food contact surfaces of the sheeter machine, hoagie machine, loaf machine, mixer, large mixer, large mixer guard, outside of the mixer bowl, ingredient bins, and handles of the ingredient bins, and
o   Buildup of dirt on the floor of the proofers.
 
7.    You failed to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant building that may constitute an attractant, breeding place, or harborage for pests as required by 21 CFR 110.20(a)(1). Specifically, during the inspection, the inspector observed vines and grass growing next to the west side of the building.
 
8.    You failed to hold and store pesticide chemicals in a manner that protects against contamination of food-contact surfaces as required by 21 CFR 110.35(b)(2). Specifically, the inspector observed unused equipment on the southwest wall, including a large unused mixing bowl with old flour with apparent insect tracks and debris inside.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products or injunction.
 
We request that you notify this office in writing, within 15 working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you can not complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
 
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover 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.
 
Your response should be directed to: Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions, please do not hesitate to call CO Hensley at (913) 495-5183 or send her an email at Jessica.hensley@fda.hhs.gov.
 
 
Sincerely,
/S/ 
John W. Thorsky
District Director
Kansas City District Office
 
 
cc:       
Kansas Department of Agriculture
Division of Food Safety and Lodging
109 S.W. 9th St.
Topeka, KS 6661