CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes: FDA Warning Letter to Shineluck Foods, Inc., 2026-04-29
Letter issued · posted to fda.gov .
Subject as published: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
TL;DR
At a glance: FDA issued a Warning Letter to Shineluck Foods, Inc. on 2026-04-29 citing: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shineluck-foods-inc-720155-04292026
Argus analysis
Shineluck Foods, Inc. (MARCS-CMS 720155) received an FDA Warning Letter dated April 29, 2026 from the Human Foods Program. The letter cites: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 26, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
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 Shineluck Foods, Inc. MARCS-CMS 720155 — April 29, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Charles C. Li Recipient Title Owner Shineluck Foods, Inc. 1919 W. 43rd St. Chicago , IL 60609-3116 United States Issuing Office: Human Foods Program United States April 29, 2026 WARNING LETTER CMS # 720155 Dear Mr. Charles C. Li: The U.S. Food and Drug Administration (FDA) inspected your firm located at 1919 W. 43rd St., Chicago, IL 60609-3116 on October 7, 2025, through October 14, 2025. Our current inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety regulation), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112). Based on FDA’s inspectional findings, we have determined that your mung bean sprouts are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the Produce Safety regulation is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)]. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov. This inspection resulted in FDA’s issuance of a Form FDA 483, Inspectional Observations (FDA 483) listing the observations FDA made at your farm during our inspection. To date, we have not received a response to the FDA 483. Our previous inspection of your firm, conducted from August 28, 2023 through September 18, 2023, also resulted in the issuance of an FDA 483. Some observations made during our September 2023 inspections were repeated during our current inspection, as indicated below. During the current inspection, our FDA investigator observed the following significant violations of the Produce Safety regulation, 21 CFR Part 112: 1. You did not implement a written environmental monitoring plan designed to identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment, as required by 21 CFR 112.145(a). Specifically, your “Shineluck Foods Inc. Standard Operating Procedure: Operations ENVIRONMENTAL LISTERIA MONITORING” states in part, “ (b)(4) ”. However, since September 2023, your firm collected environmental samples for Listeria spp . only (b)(4) . You did not collect any samples for the 22 months in between September 2023 and July 2025, nor did you collect any samples for September 2025. This is a repeat observation from the previous FDA inspection. 2. You did not test spent sprout irrigation water (SSIW) from each production batch of sprouts for E. coli O157:H7 and Salmonella species, as required by 21 CFR 11…
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
- Is the FDA warning letter to Shineluck Foods, Inc. publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shineluck-foods-inc-720155-04292026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- 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.
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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). CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes: FDA Warning Letter to Shineluck Foods, Inc., 2026-04-29. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-shineluck-foods-inc-2026-04-29-cgmp
"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes: FDA Warning Letter to Shineluck Foods, Inc., 2026-04-29." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-shineluck-foods-inc-2026-04-29-cgmp.
Argus HQ Research. "CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes: FDA Warning Letter to Shineluck Foods, Inc., 2026-04-29." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-shineluck-foods-inc-2026-04-29-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_shineluck_foods_inc_2026_04_29_cgmp_2026,
title = {CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes: FDA Warning Letter to Shineluck Foods, Inc., 2026-04-29},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-shineluck-foods-inc-2026-04-29-cgmp},
note = {Accessed: July 13, 2026}
}