2026-03-27 FDA Warning Letter: J&B Food Consulting Cited for Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
The short version: The FDA issued a warning letter (CMS # 720186) on March 27, 2026, to J&B Food Consulting (CEO Jay J. Lee, La Habra, CA), citing violations of the Foreign Supplier Verification Program (FSVP) regulation during an inspection conducted September 11-18, 2025. The inspection was triggered by FDA detection of Salmonella in six samples of pet treat products imported by J&B between October 2024 and April 2025 (lamb lung, pork femur bone, and beef lung sticks); suppliers were subsequently placed on Import Alerts #71-04 and #72-03 for Salmonella contamination. J&B failed to develop, maintain, and follow an FSVP for these animal foods and misidentified its foreign supplier, incorrectly claiming a labeling-only entity qualified for modified FSVP requirements under a food safety systems recognition arrangement that does not cover animal food articles.
Argus analysis
# FDA Warning Letter Analysis: J&B Food Consulting
**Company Background and Findings**
J&B Food Consulting, a California-based importer serving as a U.S. agent for foreign pet treat manufacturers, received a Warning Letter from FDA's Office of Inspections and Investigations on March 27, 2026. The inspection, conducted September 11–18, 2025, followed FDA detection of Salmonella in six samples of pet treats imported by the company between October 2024 and April 2025. Products included lamb lung, pork femur bone, and beef lung sticks. The contaminated lots triggered Import Alerts 71-04 and 72-03 (detention of pet treats and pig ears due to Salmonella presence), issued between December 2024 and May 2025.
**Regulatory Citations and Their Meaning**
The violations center on the Foreign Supplier Verification Program (FSVP) regulation at 21 CFR Part 1, Subpart L, implementing Section 805 of the FD&C Act. Specifically, J&B Food Consulting failed to: develop and maintain a written FSVP (21 CFR 1.502); conduct written hazard analysis for imported foods (21 CFR 1.504); evaluate foreign suppliers' performance and document supplier approval (21 CFR 1.505); establish written verification procedures (21 CFR 1.506); and investigate and document findings when food safety concerns emerged (21 CFR 1.508). The letter notes the company incorrectly identified a labeling entity as its foreign supplier, misapplying regulatory exemptions intended for other contexts.
**Response Timeline and Industry Implications**
As of the March 2026 letter date, FDA had received no response to the September 2025 Form FDA 483a observations. Competitors and peer importers should monitor whether J&B Food Consulting submits corrective action documentation and whether FDA pursues enforcement action under Section 801(a)(3) of the FD&C Act. The case underscores FDA's scrutiny of pet treat importers post-Salmonella contamination and the necessity of maintaining documented FSVP activities independent of foreign entity certifications.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER J&B Food Consulting MARCS-CMS 720186 — March 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Mr. Jay J. Lee Recipient Title CEO J&B Food Consulting 380 W. Pebble Beach Ave La Habra , CA 90631-2000 United States Issuing Office: Office of Inspections and Investigations United States March 27, 2026 WARNING LETTER Re: CMS # 720186 Dear Mr. Lee: From September 11, 2025, through September 18, 2025, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of J&B Food Consulting, located at 380 W. Pebble Beach Avenue, La Habra, CA 90631-2000, serving as the United States (U.S.) agent for (b)(4) . This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 384a] and the implementing FSVP regulation in Title 21, Code of Federal Regulations, Part 1, Subpart L (21 CFR part 1, subpart L). As the FSVP U.S. agent (b)(4) , J&B Food Consulting constitutes an importer for purposes of the FSVP regulation (see 21 CFR 1.500). 1 As of the date on this letter, we have not received any responses from you following this inspection. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the U.S. has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals. The inspection was initiated due to findings of Salmonella in six (6) samples, collected and analyzed by FDA, from several pet treat products imported by your company and manufactured by (b)(4) . These six (6) samples were collected by FDA between October 3, 2024, and April 16, 2025. FDA considers the lots of animal food from which these samples were collected to be adulterated under section 402(a)(1) of the FD&C Act [21 U.S.C. 342(a)(1)], in that they bear or contain a poisonous or deleterious substance which may render them injurious to health. Following the positive sample results, these (b)(4) suppliers were placed on Import Alert #71-04, “Detention Without Physical Examination of Food for Animals Due to the Presence of Salmonella ,” and/or Import Alert #72-03, “Detention Without Physical Examination of Pig Ears and Other Pet Treats Due to the Presence of Salmonella ,” 2 between December 4, 2024, and May 19, 2025. During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L, for the animal foods you import. Because of these significant violations, you are not in compliance with…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has J&B Food Consulting had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for J&B Food Consulting as of 2026-07-14. Argus ingests new FDA enforcement records daily.
- What FDA violations was J&B Food Consulting cited for?
- The FDA Warning Letter to J&B Food Consulting (issuing office: Office of Inspections and Investigations) cites: Foreign Supplier Verification Program (FSVP). Classification: Warning Letter.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-03-27 FDA Warning Letter: J&B Food Consulting Cited for Foreign Supplier Verification Program (FSVP). Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-j-and-b-food-consulting-2026-03-27-warning-letter
"2026-03-27 FDA Warning Letter: J&B Food Consulting Cited for Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-j-and-b-food-consulting-2026-03-27-warning-letter.
Argus HQ Research. "2026-03-27 FDA Warning Letter: J&B Food Consulting Cited for Foreign Supplier Verification Program (FSVP)." Digital Empire LLC. Accessed July 16, 2026. https://argushq.ai/fda/warning-letter/fda-wl-j-and-b-food-consulting-2026-03-27-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_j_and_b_food_consulting_2026_03_27_warning_letter_2026,
title = {2026-03-27 FDA Warning Letter: J&B Food Consulting Cited for Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-j-and-b-food-consulting-2026-03-27-warning-letter},
note = {Accessed: July 16, 2026}
}