As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Bakery Project Inc. dba Delano Bakery
A food company in Kansas is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, specifically in regard to the presence of pests.
In a Jan. 4 warning letter, the FDA described an Aug. 3-27, 2021, inspection of Bakery Project Inc. dba Delano Bakery’s facility in Wichita, KS.
The FDA’s inspection revealed that the firm was not in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation and resulted in the issuance of an FDA Form 483.
Some of the significant violations:
Current Good Manufacturing Practice (Subpart B):
- The firm did not take effective measures in their food processing facility to protect against contamination of food, food-contact surfaces, or food packaging materials by pests. Specifically:
On Aug. 3, 2021, during production:
- 10 live cockroach-like insects were found inside the (redacted) 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 (redacted) 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 Aug. 3 and 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 Aug. 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 (redacted) door oven and minor ingredient prep table in the Northwest production area.
On Aug. 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 Aug. 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 (redacted) 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.
- The firm did not maintain their equipment and utensils and food containers in an adequate condition through appropriate cleaning and sanitizing as necessary. They make several different bread types, each containing different allergens such as eggs, wheat flour, and milk powder. They 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 their facility. Specifically, on Aug. 3, 2021:
- They 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 ready-to-eat (RTE) food. They set the oven mitts on various surfaces throughout the facility. The firm stated they 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 (redacted) door reach-in cooler used to store dough while it was fermenting had heavy food residue buildup on the outside where they are handled. They stated that they 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.
- The firm stated that their 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 (redacted) door oven was severely chipped and had broken/missing wooden pieces.
- Heavy dried food residue buildup was found on the belts of the (redacted) molders and the belt on the (redacted) molder. A half-smoked cigarette was found on the wire rack shelving used for ingredient/clean dish storage.
- Inside the (redacted) 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.
- The firm 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. 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 Aug. 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.
- The firm failed to clean their non-food contact surfaces in a manner and as frequently as necessary to protect against allergen cross-contact and contamination. 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 (redacted) door reach-in cooler.
- Food residue, as well as cobwebs and rust buildup, was found in the inside bottom of the (redacted) bulk ingredient wheeled bins.
- Cobwebs were found hanging underneath the belt on the (redacted) molder located closest to the (redacted) room.
- Food residue was found along the edges and front of the oven doors of the (redacted) large ovens along the South wall of the production area.
The full warning letter can be viewed here.
Marquis Worldwide Specialty Inc.
City of Industry, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 29, 2021, warning letter the FDA described a June 8-10, 2021, Foreign Supplier Verification Program (FSVP) inspection of Marquis Worldwide Specialty Inc. in City of Industry, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Organic enoki mushrooms, from their foreign supplier, (redacted) in (redacted)
- Organic oyster mushrooms from their foreign supplier, (redacted) in (redacted)
The full warning letter can be viewed here.
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