Shineluck Foods, Inc. — FDA Warning Letter, April 29, 2026: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

FDA Warning Letter — Violations FDA cited at Shineluck Foods, Inc.

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 112.144(b). Specifically, you must either: test SSIW from each production batch of sprouts for at least E. coli O157:H7 and Salmonella species, or if testing SSIW is not practicable (for example, soil-grown sprouts harvested with roots or for hydroponically grown sprouts that use very little water), test each production batch of sprouts at the in-process stage (i.e., while sprouts are still growing) for such species. You place mung beans intended for sprouting into (b)(4) growing bins, (b)(4) from (b)(4) through (b)(4) . You typically have at least (b)(4) growing bins active per week. However, you stated that you typically collect (b)(4) samples per day, (b)(4) a week, which indicates that you test SSIW from only (b)(4) growing bins each week. Additionally, a review of your SSIW test results from April 1, 2025, through October 3, 2025, revealed that only (b)(4) growing bins were sampled from the weeks of June 29, 2025, and July 6, 2025, and no samples were collected the week of August 17