Animals Controversial Corruption FDA Health

FDA Inspection Reveals Family Dollar’s Contaminated Distribution Center

What is the cost of shopping at dollar stores? How much money does the average consumer actually save? Believe it or not, shopping at discounted “dollar stores” may be costing you more than you think. On February 18th, 2022 the FDA released an alert in conjunction with the Family Dollar stores, after thousands of dead rodents, birds, and feces were discovered inside one of their manufacturing facilities1. This alert applies to four-hundred and four Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee which stocked their shelves with these products. The FDA warns contaminated products sold to consumers may be unsafe, and even dangerous for use.

In 1958 a twenty-one-year-old entrepreneur named Leon Levine set out to create a store which would sell high-quality products for under two dollars. His first Family Dollar store opened in 1959 in Charlotte, North Carolina, setting forth a chain reaction of successful discount store locations2. Fast forward to today, and the Family Dollar has over 8,000 locations throughout the United States, with 15,000 locations including Dollar Tree stores. In February 2022, over four hundred of these stores would recall almost all their products, including foods, medicines, cosmetics, pet food, and other essential products deemed contaminated by inspectors.

From the start, the company’s founder Leon Levine created a philosophy which allowed the company to profit to become to 15,000 locations that it is today. According to the Family Dollar’s website Leon Levine’s “philosophy” is so integral to the company that “he and his management team have never strayed.” “The concept is a simple one,” suggested Levine, “‘the customers are the boss, and you need to keep them happy.’” As the decades past, that initial philosophy has strayed, becoming as contaminated as their modern distribution facilties.


Family Dollar

The Family Dollar’s official recall stated that, as a follow up to a consumer complaint, the FDA launched their investigation of the Family Dollar’s distribution facility. Yet, the Family Dollar itself claims on their official website that no customer complaints have been reported in relation to the mass recall.

Following a consumer complaint, the FDA began an investigation of the Family Dollar distribution facility in West Memphis, Arkansas, in January 2022.”

Instead of an apology to their consumers, the company shared an article on its Official Website’s “Recall” section from Business Wire, which assured the public that despite the thousands of decomposing rodent and bird carcasses, fecal matter, and the potential for Salmonella, ‘to date nobody had complained.’ In fact, the Family Dollar was ‘unaware’ of any negative consequences of their disgusting condition of their distributors.

“To date, Family Dollar is not aware of any consumer complaints or reports of illness related to this recall.”

The Family Dollar issued a casual “voluntary retail level product recall” of “certain products,” due to “rodent activity.” The company failed to make any other visible statements which could assure future customers that their products would not be contaminated with

The FDA announced they would be working together with the Family Dollar to initiate the voluntary recall of the effected products. These contaminated products include eyedrops, vitamins, pain medicine, shampoos, baby wipes, baby oil, contact lens cleaner, bandages, dental products, birdseed, pet treats, and human foods. This means people, and animals, have been ingesting unknown substances, including administering these substances in their eyes.

In an effort to prevent residual damage, the FDA’s Family Dollar’s Health Alert warned that, consumers are advised to “wash their hands immediately after handling any products” purchased from the Family Dollars stores. Food in glass containers and all-metal cans, can be “washed thoroughly” before consuming, as the Family Dollar announced these items still “may be suitable for use.” Customers with health concerns are encouraged to reach out to a health care professional if there are additional interests after consuming, using, or handling the contaminated foods.

Sourced FDA Statements:

“The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated.”

“The FDA is working with the company to initiate a voluntary recall of the affected products.”

“This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. 1, 2021, through the present. Some examples of these products include human foods (including dietary supplements (vitamin, herbal and mineral supplements)), cosmetics (skincare products, baby oils, lipsticks, shampoos, baby wipes), animal foods (kibble, pet treats, wild bird seed), medical devices (feminine hygiene products, surgical masks, contact lens cleaning solutions, bandages, nasal care products) and over-the-counter (OTC) medications (pain medications, eye drops, dental products, antacids, other medications for both adults and children).”

“Consumers are advised not to use and to contact the company regarding impacted products.”

“The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded.”

“Food in non-permeable packaging (such as undamaged glass or all-metal cans) may be suitable for use if thoroughly cleaned and sanitized.”

“Consumers should wash their hands immediately after handling any products from the affected Family Dollar stores.”

“Consumers who recently purchased affected products should contact a health care professional immediately if they have health concerns after using or handling impacted products.”

Rodent contamination may cause Salmonella and infectious diseases, which may pose the greatest risk to infants, children, pregnant women, the elderly and immunocompromised people.”

Following a consumer complaint, the FDA began an investigation of the Family Dollar distribution facility in West Memphis, Arkansas, in January 2022.”

“Family Dollar ceased distribution of products within days of the FDA inspection team’s arrival on-site and the inspection concluded on Feb. 11.”

“Conditions observed during the inspection included live rodents, dead rodents in various states of decay, rodent feces and urine, evidence of gnawing, nesting and rodent odors throughout the facility, dead birds and bird droppings, and products stored in conditions that did not protect against contamination.”

“More than 1,100 dead rodents were recovered from the facility following a fumigation at the facility in January 2022.”

“Additionally, a review of the company’s internal records also indicated the collection of more than 2,300 rodents between Mar. 29 and Sep. 17, 2021, demonstrating a history of infestation.”

“Family Dollar, Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the present due to the presence of rodents and rodent activity at Family Dollar Distribution Center 202.”

“There are numerous hazards associated with rodents including the potential presence of Salmonella. Use or consumption of affected products may present risk of illness due to the potential presence of Salmonella, an organism which can cause serious and sometimes fatal infections in infants, young children, frail or elderly people, pregnant persons, persons with pre-existent pathology (e.g., patients with cancer undergoing chemotherapy treatments, organ transplant recipient, etc.) and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.”

Distribution Center 202

The infamous Distribution Center 202 opened in 1994 and is approximately 850,000 square feet3. Family Dollar’s West Memphis, AR Distribution Center distributes products from the facility to stores located in Arkansas, Louisiana, Texas, Oklahoma, Missouri, Illinois, Kentucky, Tennessee, Georgia, Alabama, and Mississippi. Videos online surfaced which showed rats inside the distribution center, contaminating the company’s products. This isn’t the first time the Family Dollar or its distributors have been accused of unsanitary conditions, and unethical practices. The Family Dollar is owned by a larger entity, the Dollar Tree, which allows the companies to gain more profits under the guise of inexpensive quality products, when in reality these are defective, contaminated, toxins.


Family Dollar Tree Alliance

In 2014 the Dollar Tree stores publicly announced they would purchase Family Dollar, with the goal of reaching lower-income customers, and “diversify” their “store footprint4.”

“This acquisition will extend our reach to lower-income customers and strengthen and diversify our store footprint,” Bob Sasser, Dollar Tree’s Chief Executive said in a statement.”

The acquisition of the Family Dollar allowed the Dollar Tree to achieve an advantage and dominate the market for many lower income communities, where many families rely on the low-cost availability of the company’s food and medicine. In some places around the world, the Family Dollar, or the Dollar Tree are the only options available to gain equal access to what is touted as “quality discounted” food and medicine.

Using the Family Dollar’s name, and reliant customer base, the Dollar Tree set out to revolutionize the dollar store industry, through sourcing the cheapest possible ingredients, so at even the low cost of a dollar, the company would be able to produce a significant profit. The Dollar Tree’s headquarters are located in Chesapeake, VA5.


Greenbrier International

Greenbrier International, Inc6. is also located in Chesapeake, VA, featuring 200 total employees across all of its locations. Greenbrier generates $101.16 million in sales, with 15,756 companies in the Greenbrier International, Inc. network7.

On November 14th 2019 the U.S. Food and Drug Administration (FDA) issued a warning letter8 to Greenbrier International, dba the Dollar Tree for purchasing over the counter drugs from foreign manufacturers found to have serious violations of federal law.

The FDA’s warning letter charged Greenbrier with the use of contracted manufacturers who did not test raw ingredients before using them to make cheap drugs. In addition, Greenbrier has been charged by the FDA of relying on companies which do not test finished drugs for potential hazards including dangerous microorganisms before distribution, and even falsify their own testing records, resulting in ineffective drugs.

Greenbrier has contracted Shanghai Weierya Daily Chemicals Factory for manufacturing and supply, as well as Hangzhou Zhongbo, Bicooya, Ningbo Pulisi Daily Chemical Products, and other known repetitive and consistently significant offenders of FDA violations. Greenbrier is a company known for distributing adulterated products throughout the U.S. market.

Shanghai Weierya Daily Chemicals Factory –

“1. Import records reviewed indicated that your firm received Acne Treatment Pads and (b)(4) from Shanghai Weierya Daily Chemicals Factory, FEl 3010166363, on October 9, 2017 and November 3, 2017, respectively. significant CGMP violations, including the failure to conduct component identity testing (21 CFR 211.84(d)(1)) and the failure to test each batch of drug for objectionable microorganisms prior to distribution (21 CFR 211.165(b)). As a result of these and other violations, Shanghai Weierya Daily Chemicals was placed on lmport Alert 66-40 on September 14, 2017 and issued a warning letter on February 7, 2018. FDA copied your Chief Operating Officer (COO) on the outgoing warning letter.”

Hangzhou Zhongbo Industrial Company –

“2. lmport records reviewed indicated that your firm received various (b)(4) and (b)(4) drug products from Hangzhou Zhongbo Industrial Company, Ltd., FEI 3008229416, from October through December of 2018. An inspection of Hangzhou Zhongbo Industrial Company, Ltd. in April of 2018 revealed significant CGMP violations, including the failure to test each batch of drug for conformance with specifications prior to release (21 CFR 211.165(a)). As a result of this and other violations, Hangzhou Zhongbo lndustiial Company, Ltd. was placed on Import Alert 66-40 on September 28, 2018 and was issued a warning letter on November 27, 2018. FDA copied your COO on the outgoing warning letter.”

Greenbrier Headquarters –

“We [FDA] note that during the inspection of your [Greenbrier, dba Dollar General] corporate headquarters, you stated that if you were made aware that a warning letter was issued to one of your suppliers or contract manufacturers, you would not purchase over-the-counter (OTC) drug products from that contract manufacturer any longer. Additionally, in your February 5, 2019 response you state, ‘If a drug product is placed on Import Alert 66-40 (appearing not to comply with drug manufacturing cGMPs), Greenbrier ceases importing drug products from that establishment.’ The import data detailed above demonstrate this is not always the case.”

Greenbrier’s History –

“We [FDA] also note that Greenbrier has, at various points in time, used contract manufacturers and suppliers with histories of significant drug CGMP violations.”

“1. (b)(4), FEI (b)(4), which was issued a warning letter on (b)(4), for, among other things, not testing raw materials prior to use in drug manufacturing and not testing finished drug products prior to distribution.”

“2. Bicooya Cosmetics Limited, FEI 3010671652, which was issued a warning letter on August 11, 2017. This firm was also placed on Import Alert 66-40 on June 29, 2017, for, among other things, not testing finished drug products prior to distribution and for rodent feces found throughout the manufacturing facility. FDA copied your COO on the warning letter.”

“3. (b)(4) , FEI (b)(4), which was issued a warning letter on (b)(4). This firm was also placed on Import Alert 66-40 on (b)(4) for, among other things, falsifying test results and releasing sub-potent drugs to the U.S. market. FDA copied your COO on the warning letter.”

“4. Ningbo Pulisi Daily Chemical Products Company, FEI 3003727322, which was issued a warning letter on August 13, 2019. This firm was also placed on Import Alert 66-40 on June 10, 2019, for, among other things, not testing raw materials for identity prior to use in drug manufacturing, and not testing finished drug products prior to release. FDA copied your COO on the warning letter.”

“For manufacturers that are listed on Import Alert 66-40 for failure to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B), FDA has evidence that the drugs noted in the Import Alert appear to be adulterated. You are responsible for ensuring that the drugs you distribute are manufactured in compliance with all relevant CGMP requirements for drugs. Up to elate information regarding import alerts can be found at the following FDA website: https://www.accessdata.fda.gov/cms_ia/ialist.html.”

The FDA’s Response –

“Considering that FDA has found a pattern of drug manufacturers with serious CGMP violations in your [Greenbrier, Dollar Tree] supply chain, in response to this letter, provide a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce, in violation of section 301 (c) of the FD&C Act, 21 U.S.C. 331(c).”

“Items in your [Greenbrier, Dollar Tree] plan should include a full evaluation of your supplier and contract manufacturer evaluation program, including a plan to audit your [Greenbrier, Dollar Tree] suppliers.”

“Furthermore, you should also include a full reconciliation of any drugs from the manufacturers listed above, as well as for all firms or drugs currently on FDA import alerts, to determine if you have any remaining drugs in your possession, either in your [Greenbrier, Dollar Tree] distribution network or in retail stores under the Dollar Tree, Family Dollar, or any other retail store brands in your network. FDA encourages entities that engage in manufacturing related solely to drug distribution (e.g., distributors, brokers, private label distributors, own label distributors) to follow recommendations in FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.”


Bureau Veritas

Bureau Veritas9 is claimed to be a world leader in both inspection and certification services. Their website states that the Bureau focuses on the “quality, health and safety, environmental protection and social responsibility.”

In their formal statement involving the Family DollarBureau Veritas (BVS) publicly asserted that the test results were not suitable to make decisions of drug products for distribution into the U.S. supply chain. This means the Dollar Tree attempted to deceive the FDA inspections of their products in the past by using a third-party testing facility. Although Bureau Veritas is stated to be “a world leader” in inspections and certifications, they are not able to regulate the quality control for drugs that are sold throughout America. Thankfully, regulatory measures are in store for all ingredients and medicine that is manufactured, distributed, and sold in the United States.

“You [Greenbrier, Dollar Tree] have a contractional relationship with Bureau Veritas (BVS) to conduct testing of articles (including drugs) that you distribute.”

“FDA inspections of the aforementioned contract manufacturers and suppliers revealed that you [Greenbrier, Dollar Tree] directed your contract manufacturers and suppliers to use BVS as a contract laboratory.”

“FDA also collected a copy of your [Greenbrier, Dollar Tree] quality manual at an FDA inspection of a BVS laboratory that indicates you require your contract manufacturers and suppliers to use BVS to test drugs distributed by Greenbrier International/Dollar Tree.”

“Both during this FDA inspection, and in subsequent written correspondence submitted to the FDA, BVS representatives asserted that BVS’s test methods were not suitable for drug CGMP purposes and that its test results were not suitable to make release decisions of drug products for distribution into the U.S. supply chain.”

“Your [Greenbrier, Dollar Tree] purchasing agreements require suppliers to use BVS testing for the purpose of acceptance of distributed drugs, despite the fact that BVS could not provide adequate assertion of drug quality. This testing cannot be used as a substitute for testing required under FDA regulations. You [Greenbrier, Dollar Tree] are responsible for ensuring that the drugs you distribute are not adulterated, including ensuring that all drug manufacturers supplying Greenbrier with drugs have had release testing conducted in accordance with CGMP requirements.”

These cheap drugs have for years been entering the U.S. market to unknowing consumers. As a result, anyone who experiences any form of symptoms fail to make a connection to the origin of the contaminates. Instead of the notion that the company had better access to wholesale prices from the suppliers, they were actually able to source their products from the cheapest materials available, even bypass many traditional testing procedures. This allowed many top executives and affiliates to gain a massive advantage over the market deceptively increasing their revenue, at the expense of the people in the process.

Bob Sasser

On February 18th, 2022, Bob Sasser, 70, announced that he would step down from his position Executive Chairman of Dollar Tree’s Board of Directors after twenty-three years10. Could the results of these investigations have influenced his rapid departure? Or, did Bob Sasser decide that he had made enough money to flee the public spotlight, abandoning his own self-created sinking ship?

I am honored to have had the opportunity to lead this great company and work with such a talented management team to grow Dollar Tree into a leading retailer,” said Mr. Sasser.

Dollar Tree has made, and continues to make, an incredible and positive impact on the communities it serves, and I have confidence the Company will continue to build on the brand that customers have come to know and trust.”

“My time with Dollar Tree has been extremely fulfilling, and I look forward to seeing all that Mike, the Board and the leadership team accomplish in the years ahead.”

Bob Sasser’s colleges credit him for the lack of attention to detail, stating that the “Dollar Tree would not be the company it is today without Bob Sasser,” according to Gregory M. Bridgeford, Lead Independent Director.

“Under Bob’s visionary leadership, Dollar Tree made an incredible transformation from a regional retailer with less than $1 billion in annual sales to an iconic retail organization across the U.S. and Canada, with more than $25 billion in annual sales and a #111 ranking on the Fortune 500.”

“On behalf of the Board and the entire Dollar Tree organization, I want to congratulate and thank Bob for his commitment, dedication and leadership for more than two decades.”

How did Bob make so much money? Did Bob’s commitment, dedication, and leadership involve two decades of corruption, allowing the corporation to marginally expand their profit, simply by changing the sources of their products? Did Bob’s leadership involve directing less funding to the distribution centers which deliver the potentially contaminated products into the U.S. consumer market? Under Bob’s “visionary” leadership, thousands of consumers—and their pets—were subject to Bob’s inability to ensure the safety and reliability of the Family Dollar, and Dollar Tree’s products.

Bob Sasser is publicly responsible for his decisions to cut funding to distribution centers, avoid inspections, and cut corners on the costs of ingredients to make a fast profit. The trick with selling faulty products for discounted cost, learned Bob Sasser, was that blame was difficult to determine. As a result of Bob’s lack of commitment to quality, the Dollar Tree generating mass profit, while consumers unknowingly consumed toxic contaminants, thanks to the underfunding, and controlled inspections allowed by Bob Sasser. Many infants and children were also harmed due to the potential ingestion of contaminants. Additionally, pets consumed these toxic substances, leading to potentially devastating effects.

Should Bob Sasser be held legally responsible for his lack of regulation, and total commit to profit for him and his shareholders, no matter the cost?


Statements

“Families rely on stores like Family Dollar for products such as food and medicine. They deserve products that are safe,” said Associate Commissioner for Regulatory Affairs Judith McMeekin, Pharm.D. “No one should be subjected to products stored in the kind of unacceptable conditions that we found in this Family Dollar distribution facility. These conditions appear to be violations of federal law that could put families’ health at risk. We will continue to work to protect consumers.”


Conclusion

Events like these are just samples of the sanitation oversights which occur domestically in America. Entities like the Family Dollar seek to decevie regulatory administrations like the FDA, leading to the contamination and toxicity of everyday foods11. The consumers are the ones who ultimately pay the price of these deceptive tactics and fraudulant testing, leading to a variety of potential copmplications. Ingredients made in unregulated foreign countries such as China or India, can incorporate polluted water and other ubiquitous toxins which can enter the U.S. market causing a variety of health effects and morbidities. The possibilities of U.S, corporations profiting off of discounted international manufacturing can be reduced through rigorous FDA regulations, inspections, and enforcement. As seen with Greenbrier, despite the restrictions set in place, many companies still attempt to deceive the system to gain a profit, as often times it is difficult for the consumer to pinpoint the source of the bacteria or health effect.

Should companies like Greenbrier, The Family Dollar, and Dollar General be allowed to profit off of the American public with no repercussion for their actions?

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