2026-08-05 FDA Warning Letter: Quantum Star LLC Cited for Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
In short: FDA issued a warning letter (CMS #726568) to Quantum Star LLC on August 5, 2026, following an FSVP inspection conducted March 4-10, 2026, at the Van Nuys, CA facility. The inspection found Salmonella in pig ears imported by Quantum Star LLC and determined the company failed to develop, maintain, and follow a required Foreign Supplier Verification Program for animal foods, and failed to conduct or document a written hazard analysis despite identifying Salmonella and Listeria as potential hazards. FDA stated that failure to adequately address the violations may result in detention without physical examination of imported foods or refusal of admission under section 801(a)(3) of the FD&C Act.
Argus analysis
# FDA Warning Letter Analysis: Quantum Star LLC
**Company Background and Violations**
Quantum Star LLC, a Van Nuys, California–based importer of animal food products, received a warning letter from the FDA's Office of Inspections and Investigations on August 5, 2026, following an FSVP inspection conducted March 4–10, 2026. The inspection was triggered by Salmonella contamination discovered in pig ears imported by the company. Two separate shipments tested positive for Salmonella, prompting FDA to assess the company's Foreign Supplier Verification Program compliance. At inspection conclusion, the investigator issued Form FDA 483a observations; as of the warning letter date, Quantum Star had not responded.
**Regulatory Citations and Requirements**
The violations center on 21 CFR Part 1, Subpart L, which implements section 805 of the FD&C Act governing FSVP. Quantum Star failed to develop, maintain, and follow an FSVP for any animal foods imported—specifically pig ears from multiple foreign suppliers. Under 21 CFR 1.504(a), importers must conduct written hazard analyses identifying known or reasonably foreseeable hazards. Quantum Star told investigators it required supplier certificates for Salmonella and Listeria but could neither provide those certificates nor produce written hazard analyses. These sections require documented supplier evaluation, approval procedures, verification activities, and corrective action protocols.
**Response Timeline and Compliance Watch**
Quantum Star has fifteen working days to respond in writing to Celena Ngo, the assigned compliance officer at the Division of West Coast Imports. The letter signals potential escalation: FDA may refuse admission of imported foods, impose detention without physical examination (DWPE) under Import Alert #99-41, or pursue further enforcement. Industry peers should monitor whether the company qualifies as a "very small importer" under 21 CFR 1.512, which allows modified—though still substantive—FSVP requirements. Failure to remediate adequately may result in import refusal actions against future shipments.
Severity context
Medium severity. Typically labeling, misbranding, or promotional-claim matters — most peer companies will revise SKU-level copy within the response window.
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 Quantum Star LLC MARCS-CMS 726568 — August 05, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Arthur M. Nakagawa Recipient Title Chief Executive Officer Quantum Star LLC 15071 Keswick St Van Nuys , CA 91405-1133 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States August 05, 2026 WARNING LETTER CMS # 726568 Dear Mr. Nakagawa: From March 4, 2026 through March 10, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Quantum Star LLC, located at 15071 Keswick St, Van Nuys, CA 91405-1133. 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 (CFR) part 1, Subpart L (21 CFR part 1, Subpart L). The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable United States 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. This inspection follows findings of Salmonella in animal food you import. In (b)(4) , FDA sampled and found Salmonella in pig ears imported by your company and manufactured by (b)(4) . A subsequent shipment you imported in (b)(4) was also found to contain Salmonella . You were notified of the positive sample results, the pig ears were (b)(4) .” 1 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 section 805 of the FD&C Act. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited. 2 At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations issued on March 10, 2026. To date, we have not received your response to the Form FDA 483a. Your significant violation of the FSVP regulation is as follows: You did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the animal foods you import, including the following foods: (b)(4) Pig Ears imported from (b)(4) , located in the (b)(4) . (b)(4) Pig Ears imported fr…
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 does a "medium" severity rating mean for this letter?
- Medium severity. Typically labeling, misbranding, or promotional-claim matters — most peer companies will revise SKU-level copy within the response window.
- 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 Quantum Star LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Quantum Star LLC as of 2026-09-22. Argus ingests new FDA enforcement records daily.
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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). 2026-08-05 FDA Warning Letter: Quantum Star LLC Cited for Foreign Supplier Verification Program (FSVP). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-quantum-star-llc-2026-08-05-warning-letter
"2026-08-05 FDA Warning Letter: Quantum Star LLC Cited for Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-quantum-star-llc-2026-08-05-warning-letter.
Argus HQ Research. "2026-08-05 FDA Warning Letter: Quantum Star LLC Cited for Foreign Supplier Verification Program (FSVP)." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/fda/warning-letter/fda-wl-quantum-star-llc-2026-08-05-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_quantum_star_llc_2026_08_05_warning_letter_2026,
title = {2026-08-05 FDA Warning Letter: Quantum Star LLC Cited for Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-quantum-star-llc-2026-08-05-warning-letter},
note = {Accessed: September 23, 2026}
}