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WARNING LETTER
•J&B FOOD CONSULTING•September 18, 2025

J&B FOOD CONSULTING – FDA Warning Letter, Sep 18, 2025

Record Details

The U.S. Food and Drug Administration (FDA) issued a warning letter to J&B Food Consulting following an inspection conducted from September 11 to September 18, 2025. This regulatory action follows the company"s failure to comply with Foreign Supplier Verification Program (FSVP) requirements under the Federal Food, Drug, and Cosmetic Act. The investigation was initiated after FDA laboratory analysis detected Salmonella in several imported pet treat products, including lamb lung, pork femur bones, and beef lung sticks, which rendered the food adulterated and unfit for distribution.

The FDA identified significant safety violations, primarily the company"s failure to develop and follow a formal FSVP for its animal food imports. Despite receiving notices regarding contaminated products, J&B Food Consulting did not investigate whether their verification programs were adequate. Additionally, the firm failed to conduct necessary hazard analyses or evaluate the performance and risks associated with their foreign suppliers. A notable concern involved the firm"s reliance on safety records written in a language they could not understand, which prevented a qualified individual from properly assessing food safety risks.

The firm’s management incorrectly assumed they were exempt from certain regulations due to a misunderstanding of supplier definitions and international food safety arrangements. Consequently, the FDA has mandated a written response within 15 working days. This response must include a detailed plan for correcting these deficiencies and documentation, such as updated hazard analyses and supplier evaluation procedures, to prove implementation of a compliant safety program. Failure to address these violations may result in the FDA refusing the admission of future imports.

Company
J&B FOOD CONSULTING
Inspection date
September 18, 2025
Product type
other
Office
Division of West Coast Imports
Person
  • Jay J. Lee
View Company Profile

ID · 004636b4-8c19-49ef-b580-3c013082cf4a

Violation Codes10
FD&C Act 80521 U.S.C. 384a21 CFR 2121 CFR 1.500FD&C Act 402(a)(1)21 U.S.C. 342(a)(1)FD&C Act 301(zz)21 U.S.C. 331(zz)21 CFR 1.502(a)21 CFR 1.513

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