What happened
Original notice title
Dollar Tree, Inc. MARCS-CMS 629509, November 08, 2022
From the archived source record
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. 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. 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.
What the official notice says to do
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Read the official notice →Status and source details
- Status recorded in the archive
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- e80ad63ed20e
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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