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          Dollar Tree, Inc. - 629509 - 11/08/2022Warning Letters WARNING LETTER
      Dollar Tree, Inc.
            
      MARCS-CMS 629509 —           November 08, 2022


    
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Recipient:

                      Recipient Name
              Mr. Michael A. Witynski
                                Recipient Title
              Chief Executive Officer
          
            Dollar Tree, Inc.

                      Family Dollar Distribution Inc.
          
                      500 Volvo ParkwayChesapeake, VA 23320United States            

       Issuing Office:
        
         
          Office of Human and Animal Food Operations – West Division 3
        
         
          United States

 

 

Dear Michael A. Witynski:

The United States Food and Drug Administration (FDA) inspected your facility, Family Dollar Distribution Inc., located at 1800 Family Dollar Parkway, West Memphis, AR 72301 from January 11, 2022 through February 11, 2022. Your facility holds and distributes various human foods, including dietary supplements; animal foods; cosmetics; over-the-counter drugs (OTC drugs); and devices. Based on the inspectional findings, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

Under section 301(a) of the Act [21 U.S.C. § 331(a), the introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a food, drug, device, or cosmetic, if such act is done while the products are held for sale after shipment in interstate commerce and results in the products being adulterated.  You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

We acknowledge your 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 January 1, 2021 through March 18, 2022 due to the presence of rodents and rodent activity at the Family Dollar Distribution Center. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations, dated February 11, 2022. FDA received your written responses to those observations on March 7; March 22; April 8; May 6; June 10; July 15; August 19; and September 30, 2022. In your May 6, 2022, letter, you state that you are permanently closing the facility. We have reviewed your responses and we discuss your significant violations and your corrective actions below.

**Adulterated Human Foods and Dietary Supplements**

The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods under Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). These violations cause your human food and dietary supplement products to be adulterated within the meaning of section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that your products consist in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food and section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] 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. You did not take effective measures to exclude pests from your holding areas and to protect against contamination of food on the premises by pests as required by 21 CFR 117.35(c). Specifically, our 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 your facility by aisles **(b)(4)** and **(b)(4)**

• Significant gnawings, REPs TNTC, and a strong odor of rodent urine and excreta on a pallet containing **(b)(4)** cases of mixed nuts stored in rack location **(b)(4)**. 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 **(b)(4)** layer down to the 3rd layer of the pallet.

• REP and **(b)(7)(E)** 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 **(b)(4)**. Eleven of the **(b)(4)** 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 **(b)(4)**.

• Approximately 30 REPs in and around a pallet containing **(b)(4)** cardboard cases with twelve 5.6-ounce pouches of Chicken Flavor Rice & Pasta Blend product stored in rack location **(b)(4)**. This pallet also had nesting material and tunnelling in between the bottom layers 1 and 2 of the pallet and at the top (**(b)(4)**) layer. Approximately 20 of the cases on the pallet contained significant rodent gnawings.

• Four rats crossing aisle **(b)(4)** from east to west near the south side of the aisle and two more rats crossing aisle **(b)(4)** from west to east near the south side of the aisle. Food is stored along the entirety of the floor levels of aisles **(b)(4)**.

• At least 5 rats were noted in rack location **(b)(4)**, which is in the northeast corner of one of the two food storage areas in your 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 **(b)(4)**. According to firm management, the General Manager closed the ICC and breakroom in October 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 (**(b)(4)** and **(b)(4)**, 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 (samples 1124522, 1179824, and 1179931) and an animal food product (sample 1176277), product packaging, and a filth sample (sample 1176276). 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 your pest control records. Reports from your pest control company documented the capture of between 16 and 107 rodents for all months of 2020 and January – June of 2021. In addition, your maintenance team conducted additional monitoring and tracking of rodent captures made in large bait boxes and glue traps placed by your pest control company along the pick-slot level of aisles **(b)(4)**. Between the dates of March 29, 2021 to September 17, 2021, your firm documented over 2300 rodent captures. Following a facility fumigation between January 16 - January 20, 2022, approximately 1100 rodent carcasses were “harvested” or removed from your facility by firm employees and your pest control company.

• According to internal emails reviewed during the inspection, your firm was contacted by stores as far back as December 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. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated as required by 21 CFR 117.35(a). Specifically, insanitary conditions were observed throughout your facility demonstrating that sanitation and cleaning operations were not conducted in a manner that protects against contamination of food. These insanitary 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 **(b)(4)** and #**(b)(4)**.

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 **(b)(4)** 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 **(b)(4)** 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 **(b)(4)** and **(b)(4)** had gaps up to 3 inches in length and 1 inch in height around the doors, and receiving doors **(b)(4)**, **(b)(4)** and **(b)(4)** were observed to have gaps at least 2 inches in height and 6 inches in length. Shipping doors **(b)(4)** and **(b)(4)** were observed to have approximately 2-inch gaps running the entirety of each side of the dock plates.

• Your 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. You did not keep grounds around your plant in a condition that would protect against the contamination of food as required by 21 CFR 117.20(a). Specifically, you 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 by 21 CFR 117.20(a)(1). 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 compacter 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.

**Adulterated Cosmetics**

4. The cosmetic products that you hold and distribute are adulterated within the meaning of section 601(c) of the Act [21 U.S.C. § 361(c)] 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. Specifically, during the January 11, 2022 to February 11, 2022 inspection of your West Memphis, Arkansas facility, our investigators observed insanitary conditions that may cause your cosmetic products to be contaminated with filth or rendered injurious to health. Specifically, there was apparent filth and evidence of rodent activity throughout the warehouse, and the equipment and facility are not maintained to prevent the contamination of the cosmetic products. For example, our investigators observed the following:

• Rodent excreta pellets on and around cosmetic products stored in your facility.

• Multiple dock doors and dock plates in both shipping and receiving areas with gaps ranging in size exposing the facility to the environment.

• Multiple holes in rubber sealants and gaps surrounding pipes and wiring exiting the building.

• Heavy buildup of dust and debris around and under pallets storing cosmetic products.

**Adulterated Animal Foods**

The inspection of your facility revealed evidence of significant violations of FDA’s regulations for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals under Title 21, Code of Federal Regulations, Part 507 (21 CFR 507). These violations cause your animal food products to be adulterated under section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that your products consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food and under section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] 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.

5. Your firm failed to hold animal food for distribution under conditions that protect against contamination and minimize deterioration in accordance with 21 CFR 507.27(a). Specifically, during the inspection, investigators documented insanitary conditions in the area of your warehouse where bagged pet foods are stored. The insanitary conditions observed by our investigators include significant rodent activity, such as gnaw holes in packaging material, rodent excreta pellets, nesting materials, urine stains, live rodents, and rodent carcasses. These conditions were observed in the center of each of the **(b)(4)** food areas of your warehouse, consisting of aisles **(b)(4)** and **(b)(4)**. These conditions were also observed in all four corners and the center of the warehouse.

6. Your firm failed to take effective measures to exclude pests and protect animal foods from contamination by pests as required by 21 CFR 507.19(e). Specifically, your firm’s failures at preventing, controlling, and mitigating an active rodent infestation were described under the human foods observations 1-2 above. The animal foods stored and distributed at your warehouse were under the same conditions and exposed to the same insanitary conditions as the human food products. The extent of the rodent activity in the facility was documented through the collection of a filth sample (1176276) which included REPs and nesting material from all four corners of the warehouse that confirmed the presence of rodents throughout the warehouse. Additional observations or findings by FDA Investigators of rodent activity in and around animal food products include the following:

• Rodent gnawings on seven out of **(b)(4)** bags of High Protein Chicken & Turkey Flavored dog food stored on a pallet in rack location **(b)(4)** on the southwest corner of food area **(b)(4)** This pallet also contained TNTC apparent REPs on and around the bags of dog food.

• Approximately 40 REPs on a pallet containing **(b)(4)** bundles of four 3.15-pound bags of Tender & Crunchy Combo cat food stored in rack location **(b)(4)** One of the 3.15-pound bags also contained a circular gnaw-hole approximately 1.5 inches in diameter.

• TNTC REPs on and around a pallet containing **(b)(4)** 16-pound bags of Gravy Style Beef Flavored dog food held in rack location **(b)(4)**

• TNTC REPs on a pallet containing **(b)(4)** twelve-pound bags of Surfin’ & Turfin’ Favorites dry cat food stored in rack location **(b)(4)**. Three bags on the lowest layer of the pallet also contained gnaw holes ranging from 2 inches to 4 inches in diameter. FDA sample 1176277 of Surfin’ & Turfin animal food, collected on January 13, 2022, included the product, its packaging, and REPs was submitted for analysis. The FDA lab determined that the submitted product had urine stains and rodent hairs, the packaging had rodent gnawings and urine stains, and the REPs were determined to be of rodent origin.

In addition to the rodent infestation, investigators documented the presence of birds in and around the animal foods. Specifically, on February 1, 2022, apparent bird droppings covering an area of flooring 1.5 foot wide, and 3 feet long were observed by the northwest end of aisle **(b)(4)**. On February 9, 2022, investigators observed new bird droppings covering the same area. Aisle **(b)(4)** is primarily used for storage of pallets containing large bags of animal food. In addition to the bird droppings, a dead bird was observed caught in bird netting overtop of this area.

**Adulterated Human Drugs**

During our January 11 to February 11, 2022 inspection of your facility investigators from the FDA determined that your firm holds and distributes OTC drug products that are adulterated within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. 351(a)(2)(B)] in that the building used in the holding of drug products was not maintained in a clean and sanitary condition and was infested by rodents and other vermin as required by 21 CFR 211.56(a). The drug products held at your facility were also adulterated under 501(a)(2)(A) of the Act [21 U.S.C, 351(a)(2)(A)] in that the drug products were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.

7. During the inspection, our investigator observed filthy conditions in your facility. We observed significant rodent activity throughout the facility. We observed dead rodents and birds in various areas inside your facility, rodent urine and feces in and on several pallets containing drug products, and pungent odors in various areas inside your facility. As you are aware, rodents are disease vectors and goods contaminated with rodent feces and/or urine may cause *Salmonella* and other infectious diseases. Infants, children, pregnant women, the elderly, and immunocompromised persons are at greatest risk for infection and are more likely to have severe symptoms. Consumers can become infected by handling contaminated drugs, including packaging, and then transferring the bacteria from their hands to their mouth. Additionally, *Salmonella* on hands or clothes can spread the bacteria to other people, objects, and surfaces.

8. Products stored at your facility, including adulterated drug products, were shipped to 404 Family Dollar retail stores after being held in the above-mentioned conditions. You were aware of a rodent infestation at your facility beginning in 2020, and you continued to ship products, including drug products, to stores up until January 13, 2022 when fumigation of the facility occurred.

**Adulterated Devices**

During the inspection of your distribution center, investigators from the United States Food and Drug Administration (FDA) determined that your firm holds and distributes devices, including but not limited to, tampons, face masks, contact lens solutions, adhesive bandages, and pregnancy tests. Under section 201(h) of the Act, [21 U.S.C. § 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The devices are adulterated within the meaning of section 501(a)(2)(A) of the Act [21 U.S.C. § 351(a)(2)(A)], because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

9. Specifically, the devices held at your distribution center were exposed to significant rodent infestation and rodent excreta pellets. Investigators documented signs of rodent gnawing, and nesting material associated with long term rodent presence throughout the facility where the devices were held. The conditions described above for foods and drugs reflect the general objectionable conditions of the warehouse under which you also held devices regulated by FDA. Additionally, evidence of rodent contamination directly to devices was observed. For example:

• On February 2, 2022, FDA investigators observed a pallet of Family Wellness Pregnancy Tests, lot W00101202, located in bay **(b)(4)** with numerous rodent excreta pellets on the top of and in between cases along with nesting material and fluorescing stains.

• On February 1, 2022, FDA investigators observed a case of First Response Pregnancy Tests, expiration date 2022-12-23, located in the repack area with a rodent excreta pellet and apparent rodent hairs on top of the boxes.

We acknowledge that your firm conducted a voluntary recall of FDA-regulated devices warehoused at the West Memphis Distribution Center, RES89685, on February 18, 2022; and is conducting ongoing destruction activities of these products within your control. The FDA requests that you include in subsequent responses any ongoing or future corrective actions your firm is implementing specific to these products. Further, we request your firm provides records demonstrating the effectiveness of your corrective actions taken to reduce the presence of rodents, and other pests, in your distribution warehouse, including records of ongoing rodent control activities, such as capture numbers and their locations in your subsequent responses.

**Additional Considerations**

Your corporation received a Warning Letter (320-20-071
 sent to Greenbrier International Inc. doing business as Dollar Tree (FEI 3005269673)) on November 6, 2019, for the receipt and delivery or proffered delivery of adulterated drugs in violation of section 301(c) of the Act, [21 U.S.C. § 331(c)]. 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.2
 In light of these two separate incidents involving significant rodent infestations in your supply chain, we recommend that Family Dollar take steps to evaluate whether there are additional issues with rodent infestation in your drug supply chain.

**Cessation of Preparing, Packing or Holding FDA Regulated Articles for Distribution**

We acknowledge your decision to close the facility and cease distribution of all FDA regulated articles from the site. We reviewed your written responses dated March 7; March 22; April 8; May 6; June 10; July 15; August 19; and September 30, 2022 but do not see a need to discuss your responses further in light of your decision to close the facility.

If you plan to resume the preparing, packing or holding of FDA regulated articles for distribution at this facility, we request that you notify the FDA of your plans in writing. Remediating violations of the Act will be necessary if Family Dollar, a successor, or an acquirer resumes operations related to FDA regulated articles at this site. A meeting can be scheduled between you and the FDA to discuss the requirements.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. Your firm should investigate and determine the causes of any violations and take prompt actions to correct any violations and bring the products into compliance. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration at the following email: Chad.Whitwell@fda.hhs.gov (preferred) or you may also mail a hard copy addressed to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration at 1201 Main St, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at 214-253-5328 or by email.

Sincerely, 
/S/                    
Edmundo Garcia, Jr. 
Program Division Director 
Office of Human and Animal Food Operations 
– West Division 3

Cc:     Attn: General Manager
          Family Dollar Arkansas Distribution      
          1800 Family Dollar Pkwy
          West Memphis, AR 72301 US


1U.S. FDA Warning Letter (320-20-07) issued to Greenbrier International, Inc dba Dollar Tree on November 6, 2019: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/greenbrier-international-inc-dba-dollar-tree-574706-11062019
                      2You were also copied on the original warning letter to the contract manufacturer whose products were subsequently placed on import alert and the importation of which was cited in the Greenbriar Warning letter. See U.S. FDA Warning Letter (320-17-47) issued to Bicooya Cosmetics Limited on August 11, 2017: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bicooya-cosmetics-limited-533477-08112017

                                                                                  Content current as of:
      12/20/2022
               
                
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