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FDA Issues Warning to OTC Drug Manufacturer for Serious Quality Lapses
On June 6, 2025, the FDA issued a Warning Letter to Horizon Tool Inc. after inspecting its Greensboro, North Carolina facility in January. The site manufactures over-the-counter (OTC) products, including antibacterial soaps.
Key violations included failure to conduct microbiological testing on finished batches, lack of a written stability testing program, and inadequate identity testing of raw materials like benzalkonium chloride. These practices failed to meet U.S. Pharmacopeia (USP) standards.
The company acknowledged its procedures were “not robust enough,” but its proposed corrective actions fell short of FDA expectations. The agency emphasized that such gaps could compromise product quality and patient safety.
The full Warning Letter is available on the FDA’s website.
01-07-2025
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