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.
Dollar Tree Inc.
Dollar Tree Inc. of Virginia is on notice from the FDA for the unsanitary conditions of their distribution center, including a rodent infestation.
In a Nov. 8, 2022, warning letter, the FDA described a Jan. 11 through Feb. 11, 2022, inspection of Dollar Tree Inc.’s Family Dollar Distribution Inc. in West Memphis, AR.
The FDA’s inspection revealed that the firm had serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations, and resulted in the issuance of an FDA Form 483.
The firm initiated a voluntary recall of certain products regulated by the FDA that were stored and shipped to 404 stores from Family Dollar Distribution Inc., in West Memphis, Arkansas from Jan 1, 2021, through March 18, 2022, due to the presence of rodents and rodent activity at the Family Dollar Distribution Center.
In the firm’s May 6, 2022, response letter, they stated that they are permanently closing the West Memphis facility.
Some of the significant violations are as follows:
Adulterated Human Foods and Dietary Supplements
The inspection of the firm’s facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods. These violations cause the firm’s human food and dietary supplement products to be adulterated in that their products consist in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food and in that they have been 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.
1. The firm did not take effective measures to exclude pests from their holding areas and to protect against contamination of food on the premises by pests as required. Specifically, FDA investigators observed evidence of rodent activity, including live rodents, dead rodents in various states of decay, rodent excreta pellets (REPs) in numbers too numerous to count (TNTC), gnaw marks in food and food packaging, nesting material, and odors indicative of rodent infestation throughout the entire facility including areas where human food, including dietary supplements, are routinely stored. Below are some examples of the observations made by the investigators:
• Four rat carcasses on the conveyer belt along the south wall of the facility by aisles (redacted) and (redacted)
• Significant gnawings, REPs TNTC, and a strong odor of rodent urine and excreta on a pallet containing (redacted) cases of mixed nuts stored in rack location (redacted). Multiple bags of product were gnawed open, and product was spilling out of cases onto lower levels of the pallet. Gnawings and spilled product could be seen from the top (redacted) layer down to the 3rd layer of the pallet.
• REP and (redacted) hair on top of a pallet of Vitamin C 1000 mg dietary supplements.
• Approximately 15 REPs on a pallet of flour located in rack location (redacted). Eleven of the (redacted) cases stored on the pallet contained product with gnawings. While investigators unstacked the pallet, two mice exited from gnawed-open product bags stacked on the bottom layer of the pallet and ran west under the north end of aisle (redacted).
• Approximately 30 REPs in and around a pallet containing (redacted) cardboard cases with twelve 5.6-ounce pouches of Chicken Flavor Rice & Pasta Blend product stored in rack location (redacted). This pallet also had nesting material and tunneling in between the bottom layers 1 and 2 of the pallet and at the top ((redacted)) layer. Approximately 20 of the cases on the pallet contained significant rodent gnawings.
• Four rats crossing aisle (redacted) from east to west near the south side of the aisle and two more rats crossing aisle (redacted) from west to east near the south side of the aisle. Food is stored along the entirety of the floor levels of aisles (redacted).
• At least 5 rats were noted in rack location (redacted), which is in the northeast corner of one of the two food storage areas in the facility. Rats were climbing through the pallet in this rack location and climbing up rack scaffolding to reach upper levels.
• A strong foul odor/stench of dead and decaying rodents, rodent pellets, and evidence of rodents nesting in and around the Inventory Control Center (ICC) and the breakroom, which is located directly north of food aisles (redacted). According to firm management, the General Manager closed the ICC and breakroom in Oct. 2021 because of complaints related to strong odors associated with dead rodents. Inspectors observed that the ICC was cleared out and closed off, and a putrid odor continued to permeate the room. The breakroom above the ICC was closed and rodent nesting materials were in front of the entrance.
• Apparent bird droppings were observed on chocolate protein shakes and Vitamin C supplement drops and on the floor near the northeast side of the small food storage racks by the shipping area ((redacted) and (redacted), respectively).
• Two dead birds were observed within the facility. One bird was caught in netting hung from the roof above pallets of breakfast cereals. The second was observed on the east side of the mezzanine level under part of the old conveyor system.
In addition to visual observations, FDA documented the following findings:
• FDA collected several samples during the inspection. These samples included human food products and an animal food product, product packaging, and a filth sample. These samples were submitted to FDA labs for analysis. FDA’s analysis found the presence of urine, gnaw marks in the packaging, rodent hairs, and/or REPs in these samples. Further, the filth sample included REPs and nesting materials collected from all four corners and the center of the warehouse (including the center of each of the two food areas), demonstrating the rodent population was throughout the facility.
• FDA conducted a review of the firm’s pest control records. Reports from their pest control company documented the capture of between 16 and 107 rodents for all months of 2020 and Jan.– June of 2021. In addition, the firm’s maintenance team conducted additional monitoring and tracking of rodent captures made in large bait boxes and glue traps placed by their pest control company along the pick-slot level of aisles (redacted). Between the dates of March 29, 2021 to Sept. 17, 2021, the firm documented over 2,300 rodent captures. Following a facility fumigation between Jan. 16 – 20, 2022, approximately 1,100 rodent carcasses were “harvested” or removed from their facility by firm employees and their pest control company.
• According to internal emails reviewed during the inspection, the firm was contacted by stores as far back as Dec. 8, 2020, sharing their observations of rodent activity in deliveries of food products from the distribution center. Specifically, throughout 2021, retail stores serviced by the West Memphis distribution center emailed complaints of receiving food products gnawed by rodents, nesting materials inside of packages, and case containing both live and dead rodents from the distribution center.
2. The firm did not maintain buildings, fixtures, and other physical facilities of their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated as required. Specifically, unsanitary conditions were observed throughout their facility demonstrating that sanitation and cleaning operations were not conducted in a manner that protects against contamination of food. These unsanitary conditions provided food sources and pest harborage areas for rodents and other pests. In addition, inadequate maintenance to parts of the facility allowed for potential pest entry and harborage areas within the facility. The following are examples of insanitary conditions that were observed:
• Investigators observed spilled breakfast cereal, spilled Chicken Flavor Rice & Pasta Blend product, spilled all-purpose flour, spilled popcorn, and spilled sunflower seeds. All products had REPs mixed in with spilled product. Fluorescing stains were observed in and around the packaging for spilled flour and popcorn.
• Accumulations of trash and debris in multiple locations, including the old conveyor system located in the mezzanine level and in the “Junk Yard” portion of the warehouse, which contains maintenance equipment.
• Open packages of baby wipes were observed in the warehouse with fluorescent stains indicative of urea or urine.
• Following the fumigation of the facility, the inadequate sanitation practices became more apparent as dead pests were observed in various states of decay throughout the facility. These observations included, but are not limited to:
o Multiple dead rodents found near slots (redacted) and #(redacted).
o Dead rodents along the north wall, near the ICC and breakroom, on March 7, 2022. One was caught in a snap trap zip tied to a metal beam next to dock door (redacted) and the other was behind a metal beam against the outer wall.
o A dead bird below part of the old conveyor system on March 7, 2022.
The following are examples of inadequate maintenance conditions that were observed:
• Gaps were found along the top of the compactor that is meant to create a seal between the compactor and the exterior wall of the facility. Additionally, holes were observed in the compactor sidewall ranging from an estimated 1 inch to 12 inches on both the north and south facing sides allowing for potential pest entry. The compactor has a (redacted) door for access from the inside of the firm that is left open during business hours. While this door is open, the gaps and holes present the potential for pest entry into the facility.
• Multiple dock doors were observed to have gaps allowing for potential entry of pests into the facility. More specifically, receiving doors (redacted) and (redacted) had gaps up to 3 inches in length and 1 inch in height around the doors, and receiving doors (redacted), (redacted) and (redacted) were observed to have gaps at least 2 inches in height and 6 inches in length. Shipping doors (redacted) and (redacted) were observed to have approximately 2-inch gaps running the entirety of each side of the dock plates.
• The firm began the decommissioning of a conveyor system. Parts of the decommissioned system were left in the mezzanine level where cobwebs, dirt, dust, and debris has built up under and around these parts. This equipment became a harborage area for rodents as evidenced by the observation of a dead rodent that was seen in between the conveyor belts of the “Upper West Side Belt” and investigators noting a foul odor indicative of dead and decaying animals in another section of what would be the “Upper Southside Belt.”
3. The firm did not keep grounds around the plant in a condition that would protect against the contamination of food as required. Specifically, they did not properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests, as required. For example, throughout the inspection, FDA investigators observed the following conditions:
• Large amounts of trash (including food trash), wood from pallets, and debris were piled below dock doors and along the shipping and receiving area walls of the facility.
• Piled-up trash extending approximately 2 feet out from the walls of the facility.
• Large amounts of food trash and dirt piled below and surrounding the compactor that appeared to have spilled from a breach in the side panel of the compactor.
• Throughout the inspection, piles of food next to or spilling out of the large open-top dumpsters located on the west side of the shipping dock.
The corporation received a Warning Letter (ent to Greenbrier International Inc. doing business as Dollar Tree) on Nov. 6, 2019, for the receipt and delivery or proffered delivery of adulterated drugs. Of particular concern, the Warning Letter detailed FDA evidence that Dollar Tree, parent company of Family Dollar, distributed drugs that were manufactured at a facility where rodent feces were found throughout. In light of these two separate incidents involving significant rodent infestations in their supply chain, the FDA recommends that Family Dollar take steps to evaluate whether there are additional issues with rodent infestation in their drug supply chain.
The FDA reviewed the firms written responses but do not see a need to discuss their responses further in light of their decision to close the facility.
If the firm plans to resume the preparing, packing or holding of FDA regulated articles for distribution at this facility, the FDA requests that they notify the FDA of their plans in writing.
The full warning letter can be viewed here.
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