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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dutch-Maid Bakery 12/11/13

  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200, Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802

 

December 11, 2013
 
WARNING LETTER NO. 2014-NOL-06
 
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Cynthia L. Day, Co-Owner
Dutch Maid Bakery
111 Main Street
Tracy City, Tennessee 37387-4018
 
Dear Ms. Day:
 
On October 21-25, 2013, a U.S. Food and Drug Administration (FDA) investigator inspected your bakery, located at 111 Main Street, Tracy City, Tennessee. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These conditions cause the food products held 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 United States Code (USC) 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act through links on FDA’s Internet home page at www.fda.gov.
 
We received your firm’s response to the Form FDA 483 on November 18, 2013, and our evaluation of your response is discussed below. Violations revealed during the inspection include, but are not limited to, the following:
 
1.   Your firm failed to take 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, our investigator discovered evidence of widespread rodent activity and live and dead insect activity in, on, and near foods stored in your food processing facility. For example, the following items were discovered in the production areas of the bakery during the inspection:
 
Insect Activity
 
  • A winged insect in a partial 50 pound bag of (b)(4)
  • A winged insect in a partial 50 pound bag of (b)(4)
  • A moving insect larva in a partial 50 pound bag of (b)(4)
  • A moving winged insect in a partial 30 pound bag of (b)(4)
  • A moving winged insect in a partial 30 pound bag of (b)(4)
  • A moving winged insect in a partial 50 pound bag of (b)(4)
  • At least three winged insects and an insect larva in a metal bulk bin of powdered sugar
  • A winged insect in an opened partial 50 pound box of (b)(4)
  • A live roach-type insect in the southeast storage room, adjacent to glass canning jars along the south wall, east of the entrance to the storage room
  • Dead ants, too numerous to count, on the floor in the southeast storage room, adjacent to glass canning jars along the south wall, east of the entrance to the room
 
Rodent Activity
 
  • A dead mouse was observed on the floor under the metal rack holding baking pans and utensils.  The metal rack is located adjacent to the north side of the non-functioning oven.
  • At least 40 apparent rodent excreta pellets (aREPs) were observed in the northwest corner of the kitchen, north of the functioning oven.  At least 15 of these aREPs were located on shelves immediately adjacent to ceramic serving plates, or directly on clean ceramic and plastic serving plates and baking pans.
  • At least 20 aREPs were on the floor along the north side of the non-functioning oven, which was approximately within six inches of clean baking pans and kitchen utensils.
  • At least 10 aREPs were on the floor along the west side (front) of the non-functioning oven, which was approximately within two feet of a partial bag of yellow onions, and potatoes stored directly on the floor.
  • At least 20 aREPs were on the floor and in bread pans along the east wall behind the non-functioning oven.
  • At least 55 aREPs were on the floor under the dry/canned goods shelf along the west wall, and in the center of the room of the southeast storage room.
  • At least three aREPs were on the floor between the southeast prep table, and the south wall adjacent to the spice storage shelf.
  • At least 27 aREPs were on a concrete ledge and on the floor below the ledge, in the southwest corner of the room, adjacent to cake and cookie decorating confections and supplies.
  • At least 38 aREPs were on a shelf and the floor below the shelf, in the southwest corner of the dock/storage area adjacent to three-50 pound bags of (b)(4) stored directly on the floor.
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
2. 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 gap of approximately 1/2" x 1 1/2" was observed between the double doors near the floor juncture of the unused exterior door, located on the east side of the facility directly behind the non-functioning oven.
  • Two holes, each approximately 3" x 2", were observed in a section of plywood used to serve as an exterior wall in an approximate 4' x 8' opening in the brick wall.  The holes, which were approximately 4' up from the floor, lead directly to the exterior of the building.  Additionally, gaps in the brick wall were adjacent to the plywood which may allow pest access into the facility.
  • A basement access, located on the north side of the exterior of the building, was covered with a piece of foam panel, which did not completely cover the opening.  An approximate 1/2" gap was observed between the top of the foam panel and the opening.  Additionally, there was an approximate 3" x 3" hole in the upper right corner of the foam panel.
  • A basement access on the east side of the exterior of the facility was observed to have an entrance covered with a piece of black plastic.  The plastic was damaged in the bottom right corner creating an approximate 20" x 16" hole, and the two polymerized vinyl chloride (PVC) pipes plumbed through the plastic created additional holes.
  • An access hole in the cinder block wall, approximately 2 1/2' x 2', which leads to under the facility on the exterior of the southeast corner of the building, was observed uncovered and unscreened.  The hole led to an open area where two additional holes were observed in the cinder block foundation, allowing for further access under the building. One hole was approximately 16" x 8", while the other hole, which was created for a PVC drain pipe, was approximately 6" x 6".
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection. Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
3. Your firm failed to use rodenticides under precautions and restrictions which would protect against the contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR 110.35(c). Specifically, exposed rodenticides were observed to be broadcast in the following areas of your facility:
 
  • One open package of rodenticide pellets on the floor behind a storage shelf, located along the north wall, west of the labeling/storage room entrance
  • One open package of rodenticide pellets on a shelf in the storage closet, located in the northeast corner of the kitchen
  • Two open packages of rodenticide pellets on the floor behind the functioning oven, located along the west wall
  • One rodenticide bar on the floor on the east side (rear) of the non-functioning oven, approximately 3' from the unused exterior door, located along the east wall
  • One rodenticide bar on the floor under the dry/canned goods storage shelf, located along the west wall of the southeast storage room
  • One rodenticide bar on the floor in the center of the southeast storage room
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
4.   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 many areas in the facility to be in an insanitary condition, which included:
 
  • The floor in the food preparation area was observed to be heavily soiled and coated with food particles and dried liquids.  Areas under prep tables, between prep tables, and walls exhibited excessive debris build-up.
  • The floor and metal racks in the bread proof room were observed to be heavily soiled and coated with food particles and debris.
  • The spice shelf located along the south wall, west of the prep table in the southeast corner of the kitchen, was observed to be heavily soiled and coated with dried liquid and food particles.
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection. Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
5.   Your firm failed to manufacture, package, and store foods under conditions and controls necessary to minimize contamination, as required by 21 CFR 110.80(b)(2). Specifically, three 50 pound bags of (b)(4) were observed to be stored directly on the floor beneath and adjacent to two 50 pound bags of agricultural use only lime powder. Additionally, one bag of flour was observed to be on the floor and in contact with lime powder, which had spilled from one of the bags of lime.  The flour and lime powder were stored in the southwest corner of the dock/storage area. Numerous packages of food, including a 25 pound box of dried cranberries, two plastic containers of black pepper, a plastic container of sage powder, a partial bag of onions, and a bag of potatoes, were observed sitting directly on the floor in your facility.
 
We reviewed your response to the FDA 483 received on November 18, 2013. It appears you are working to correct the deficiencies observed during the inspection. Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
6. Your firm failed to provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food. Specifically, the following food and non-food storage areas were cluttered with various items:
 
  • The southeast storage room, where canned/dry goods are stored, contained food packaging materials, storage containers, empty boxes, equipment, and non-food items, which were stored directly against the walls and in the middle of the room. These items prevented a thorough inspection of the perimeter of the room and proper cleaning of the floor. Additionally, these items prevented the ability for an individual to pass from the entrance on the southwest side to the entrance on the northeast side of the room.
  • The storage closet located in the northeast corner of the facility contained non-food equipment, storage containers, metal shelving, hoses, and wire in such a way as to prevent the thorough inspection of the area and proper cleaning of the floor. Additionally, access to the hot water heater was completely blocked by the debris.
  • The area in northwest corner of the kitchen, north of the oven, contained plastic food service trays, plastic food bags, hot food holding equipment, food containers, utensils, and finished food label stickers in such a way as to prevent the thorough inspection of the floors, walls, and the proper cleaning of the countertop, shelves, and floor.  Numerous aREPs were observed in this area and a meat slicer was observed to be used during the inspection which is located on the same countertop.
  • The top of the non-functioning oven was observed to be covered with numerous non- food items including a live animal trap, which was stored on the northeast corner of the non-functioning oven, above the metal rack holding clean baking equipment.
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
7. 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, the following structural deficiencies were noted:
 
  • The interior walls of the food preparation area are composed of painted brick and stone, which cannot be easily cleaned.  Many areas of the wall, and specifically behind the mixing equipment, were observed to be coated with a build-up of dried food.
  • The southeast corner of the ceiling in the southeast storage room, which is composed of sheet metal, was observed to be hanging approximately six inches from its support.
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
8. Your firm failed to properly store equipment, remove litter and waste, and cut weeds or grass which 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, the investigator observed the following on the exterior side of the building:
 
  • Tall weeds and other vegetation as high as approximately 5 1/2' within the immediate vicinity to the rear of the building
  • Numerous pieces of unused equipment and building materials including a wooden pallet, metal framing, several pieces of concrete board, a wooden fence, walk-in cooler wall panels, a large pile of wood, and plywood being stored in direct contact with the exterior wall
  • Several pieces of unused equipment including an oven, a three compartment sink, bulk metal ingredient bin, and additional walk-in cooler panels and framing being stored within the immediate vicinity of the rear of the building
  • Two plastic buckets filled with standing water and egg shells stored on the concrete slab near the northeast side of the building
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
9. Your firm failed to store and dispose of rubbish to minimize the potential for waste becoming an attractant and harborage or breeding place for pests, as required by 21CFR 110.37(f).  Specifically, several bags and un-bagged items of kitchen refuse were observed to be stored in the dock/storage area, directly on the floor adjacent to the dock door. Numerous aREPs were observed in this area. Additionally, three bags of (b)(4) flour were observed to be stored directly on the floor within 10 feet of the refuse.
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
10. Your firm failed to maintain equipment, containers and utensils used to convey and hold food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically, a full cup of coffee was observed directly on the table used as the drying area for cleaned cooking equipment and utensils, immediately adjacent to clean utensils. Additionally, a full cup of coffee was observed on the table adjacent to the table used as the drying area for equipment and utensils. The top of the coffee was covered with mold, and the cup was immediately adjacent to plastic food storage containers.
 
 We reviewed your response to the FDA 483 received on November 18, 2013. It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
11. Your firm failed to properly store toxic pesticide chemicals in a manner that protects against contamination of food-packaging materials, as required by 21 CFR 110.35(b)(2). Specifically, rodenticide bait blocks were stored directly below the table used as the drying area where cleaned utensils, serving dishes, and cooking equipment were observed to be air drying and stored. The table is located adjacent to the north side of the non-functioning oven.
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
12. Your firm failed to require personnel to wear hair restraints where appropriate, as required by 21 CFR 110.10(b)(6). Specifically, four employees were observed to be working in the food production area during the inspection, and none were wearing hair restraints. 
 
We reviewed your response to the FDA 483 received on November 18, 2013. It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
13. Your firm failed to ensure personal clothing was not stored in an area where equipment or utensils are washed, as required by 21 CFR 110.10(b)(7). Specifically, a personal outer garment was lying directly on the dish and equipment drying area and in direct contact with serving plates and cooking utensils. 
 
We reviewed your response to the FDA 483 received on November 18, 2013.  It appears you are working to correct the deficiencies observed during the inspection.  Any corrective actions will be evaluated and verified during an inspection of your firm, scheduled at a later date.
 
Finally, the above listed violations are not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure your facility is operated in a sanitary manner.  The specific violations noted in this letter and in the FDA 483, issued at the close out of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
 
We are aware of your firm’s voluntary corrective actions, in response to the inspection, and conducted as our investigator brought violative conditions to your firm’s attention. Specifically, we note you voluntarily destroyed six bags of bakery ingredients and discarded the un-bagged contents of a bulk bin, which all showed signs of insect contamination.  Additionally, most of the areas revealing aREPs were cleaned.  All exposed rodenticide blocks and pellets were observed to be removed from the facility.  The majority of the floor was observed to have been cleaned and freshly painted.  The metal racks and floor in the bread proof room were observed to have been cleaned of debris.  The spice shelf, located along the south wall, was also observed clean and organized.  All food was observed stored off the floor. The southeast storage room and northwest corner of the kitchen north of the functioning oven, was observed clean and organized. The non-functioning oven, many walls within the facility, and the wooden storage shelves and ceiling in the southeast storage room, were observed to have been freshly painted, and the ceiling in the storage room had been repaired. The refuse in the dock/storage area was observed to have been removed.  The drying area had been cleared of all beverage containers.  Additionally, the drying area had been cleared of personal clothing items. You should continue to take prompt action to correct these violations. Failure to promptly correct and prevent the recurrence of these deviations may result in regulatory action such as a seizure or injunction. 
 
You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. 
 
If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
 
Section 743 of the Act (21 USC 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 USC 379j-31(a)(2)(B)]. 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 send your reply to the Food and Drug Administration, Attention: Kimberly Dutzek, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Ms. Dutzek via (615) 366-7826.
 
Sincerely,
/S/ 
Patricia K. Schafer
District Director
New Orleans District