- Delivery Method:
- Food & Beverages
Recipient NameKelly L. Dumford
- Bakery Project Inc. dba Delano Bakery
1025 W. 29th St. N
Wichita, KS 67204
- Issuing Office:
- Office of Human and Animal Food- West Division II
Dear Mr. Dumford:
The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 1025 W. 29th St. N, Wichita, Kansas 67204, on August 3, 2021 through August 27, 2021. During our inspection of your facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). During our inspection, FDA collected sample INV1133078 from your facility. FDA laboratory analysis of the sample confirmed the presence of pests, including apparent live and dead cockroaches, dead moths, insect webbing, a moth larva, and rodent excreta pellets.
Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) bread products manufactured in your facility are 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. You may find the Act and further information about the CGMP & PC rule through links on FDA's website at http://www.fda.gov.
To date we have not received a response to the FDA Form-483.
Your significant violations are as follows:
Current Good Manufacturing Practice (Subpart B):
1. You did not take effective measures in your food processing facility to protect against contamination of food, food-contact surfaces, or food packaging materials by pests, as required by 21 CFR 117.35(c). Specifically:
On August 3, 2021, during production:
• 10 live cockroach-like insects were found inside the (b)(4) proofer, located in the oven/proofer area.
• 1 live cockroach-like insect was found on the floor by the wall that separates the oven/proofer area from the mixing/prep and finish product slicing/packaging area.
• 2 dead cockroach-like insects were found inside the (b)(4) proofer on the side wall.
• 1 dead cockroach-like insect was found on top of empty finished product cardboard boxes.
• 3 dead apparent moths were found in honey residue on the outer surface area of the lid of an in-use 5-gallon bucket of honey, sitting on top of the shortening/honey prep table.
• 10 apparent rodent droppings were found along the base of the wall on the South side and on the empty stacked wooden pallets in the oven/proofer area.
• On August 3 & 4, 2021, the front door was propped open for air flow into the facility.
• Damaged or improper screening was found in the Northeast corner of the production area, South end wall of the production area, and in the screen door between the front entrance door and the production floor.
On August 4, 2021, during production:
• Numerous dead insects were found on the belts and flat surfaces of the dough divider stored on the production floor next to the (b)(4) door oven and minor ingredient prep table in the Northwest production area.
On August 10, 2021, during production:
• 1 live beetle-like insect was found on the floor next to the rolling ingredient bins under the minor ingredient prep table.
• 5 dead apparent moths were found stuck in the food residue on the blue plastic that was covering the shortening/honey prep table with an in-use bucket of honey and shortening sitting on top of the table.
On August 20, 2021, during production:
• 3 live apparent insect larvae were found between layers of packaging, and 1 live larva was found directly in contact with the flour, in the production area.
• 2 apparent insect egg sacs were found attached to the inside packaging of an open bag of flour in the production area.
• 3 live beetle-like insects were found inside an open bag of preserve product in the production area.
• 2 dead apparent insect larvae were found between layers of packaging in an open bag of preserve product in the production area.
• 20 dead apparent insects were found on the surfaces of the dough divider on the production floor next to the (b)(4) door oven in the production area.
• 6 dead cockroach-like insects were found inside a proofer on the floor.
• 3 dead cockroach-like insects were found inside another proofer on the floor and door seal.
2. You did not maintain your equipment and utensils and food containers in an adequate condition through appropriate cleaning and sanitizing as necessary, as required by 21 CFR 117.80(c)(1). You make several different bread types, each containing different allergens such as eggs, wheat flour, and milk powder. You use common equipment for these products, and do not properly clean and sanitize between making these products. Dust and dried residue containing different allergens were observed on this shared equipment and throughout your facility. Specifically, on August 3, 2021:
• You used heavily soiled oven mitts to remove trays of finished product bread from the oven. The oven mitts were occasionally coming in direct contact with the RTE food. You set the oven mitts on various surfaces throughout the facility. You stated you did not know when they were most recently cleaned.
• The metal bread racks where RTE bread loaves were placed directly on the wire shelves had food residue/dust/dirt build up on the food contact surface, and the dust/dirt was hanging from the shelves directly above RTE bread loaves.
• The 3 white food grade totes in the (b)(4) door reach-in cooler used to store dough while it was fermenting had heavy food residue buildup on the outside where they are handled. You stated that you were not sure when they were last cleaned and sanitized. Employees used their bare hands to carry the containers and bare hands to remove the dough for processing on the dough prep tables.
• You stated that your mixers had been cleaned and sanitized; however, there was heavy dried-on food residue on the food contact surfaces of the inside upper attachment area of the bread dough hook, inside the top of the mixer directly above the mixing bowl, on the lid/cover directly above the mixing bowl, and on the shield directly above the mixing bowl.
• The in-use wooden pizza peel used to remove finished product RTE bread from the (b)(4) door oven was severely chipped and had broken/missing wooden pieces.
• Heavy dried food residue buildup was found on the belts of the (b)(4) molders and the belt on the (b)(4) molder. A half-smoked cigarette was found on the wire rack shelving used for ingredient/clean dish storage.
• Inside the (b)(4) proofer, right behind the door opening on the wall/ceiling junction, there was a brown patched area that was leaking. The condensation was dripping from an area directly above the carts where bread dough was pushed in and pulled out of the proofer.
3. You failed to take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conformed to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.10(b). Specifically:
• An employee used bare hands to pick up product that had fallen onto the floor and place it in the trash can. The employee then used hand sanitizer and returned to handling RTE loaves of bread (placing them in the slicer) without washing their hands.
• Employees’ coats, purses, and lunch boxes were stored directly next to and touching ingredient containers and directly above clean equipment on the ingredient/equipment storage shelving unit.
• Employees were observed wearing heavily soiled clothing during production of RTE baked goods on August 3, 4, 10, 11, and 20, 2021.
• Employees used their bare hands to carry totes with heavy food residue buildup on the outside and then used their bare hands to remove the dough from the totes for processing.
4. You failed to clean your non-food contact surfaces in a manner and as frequently as necessary to protect against allergen cross-contact and contamination, as required by 21 CFR 117.35(e). Specifically:
• Heavy food residue/dust build-up was found on the tops of processing equipment, shelving, food prep tables, and carts throughout the facility.
• Heavy food residue build-up was found inside the bottom of the (b)(4) door reach-in cooler.
• Food residue as well as cobwebs and rust buildup was found in the inside bottom of the (b)(4) bulk ingredient wheeled bins.
• Cobwebs were found hanging underneath the belt on the (b)(4) molder located closest to the (b)(4) room.
• Food residue was found along the edges and front of the oven doors of the (b)(4) large ovens along the South wall of the production area.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify this office in writing within 15 working days of the receipt of this letter, as to the specific steps that you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Kevin A. Beavers, Compliance Officer. If you need additional information or have questions concerning any products distributed through your website, please contact CO Beavers at 417-873-9455 ext. 102 or at the above address or via email at: Kevin.email@example.com.
Dr. LaTonya Mitchell
Kansas City District Office
Program Division Director
Office of Human and Animal Food
West Division II