FDA WARNING_LETTER - Quantum Star LLC - March 10, 2026
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On August 5, 2026, the FDA issued a warning letter to Quantum Star LLC following an inspection conducted from March 4 to March 10, 2026, at its Van Nuys, California facility. The inspection was initiated after previous import shipments of pig ears were found to contain Salmonella. The primary regulatory violation is the company"s failure to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP), which is required under the Federal Food, Drug, and Cosmetic Act. The FDA found that Quantum Star LLC did not have a written hazard analysis or verification procedures for any of its imported animal foods. Although the company claimed to identify Salmonella and Listeria as potential hazards, it could not provide written documentation or safety certificates from its foreign suppliers. Under federal law, importers are responsible for verifying that foreign-produced food meets United States safety standards. Failure to correct these issues may result in the FDA refusing entry of the company"s products into the country or placing them on a detention list. The company must provide a written response within 15 working days detailing its corrective actions, including copies of its newly developed FSVP and supporting safety records.
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