FDA issued a Warning Letter to Shineluck Foods of Chicago IL, a mung bean sprout operation. There were a number of issues, specifically involving the lack of Listeria testing in the post processing environment and inadequate testing spent sprout irrigation water as required by regulation, as well as other issues. One interesting note was the retesting of one sample of spent sprout irrigation water (SSIW) where there was a positive E. coli result.
"After you received a positive E. coli O157:H7 finding in an SSIW sample, you stated that you collected another sample from the same bin on August 22, 2025, which tested negative. However, this additional test does not indicate that the SSIW was not contaminated with E. coli O157:H7 because it was conducted using a second sample from the same production batch, rather than on the same enrichment sample that resulted in the presumptive positive from the screening test."
The company could have retested 10 samples and all came out negative, but that does not negate the positive sample they did receive.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shineluck-foods-inc-720155-04292026
WARNING LETTER
Shineluck Foods, Inc.
MARCS-CMS 720155 — April 29, 2026
Recipient:
Charles C. Li
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, 2025.
3. You did not discontinue the use of all seeds from a lot for which you knew or had reason to believe were contaminated with a pathogen, as required by 21 CFR 112.142(b)(1) and you did not report the findings of microbial testing to the entity from whom you received your seeds, as required by 21 CFR 112.142(b)(2).
Specifically, on August 19, 2025, you collected SSIW from Bin (b)(4), (b)(4) growing bins of mung bean sprouts, that tested positive for E. coli O157:H7. In response, you stated (b)(4). You also did not report the information to your seed supplier. Additionally, you did not perform actions that would have allowed you to continue use of the seeds or not report the information to your supplier. Specifically, you did not treat the seeds with a process reasonably certain to achieve destruction or elimination of the most resistant microorganisms of public health significance likely to occur in the seeds, as stated in 21 CFR 112.142(c)(1), nor did you demonstrate any reasonable determination through appropriate follow-up actions that the lot of seeds was not the source of contamination, as stated in 21 CFR 112.142(c)(2).
4. You did not use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and maintained, as required by 21 CFR 112.123(a).
Specifically, on October 7, 2025 and October 8, 2025, during (b)(4) of mung bean sprouts, we observed that several strips of silicone applied to the conveyor belt, the equipment used to transport mung bean sprouts from the growing bin to the rinse water basin, were peeling and falling off in some areas while the silicone strips in other areas had already previously peeled or fallen off the belt. We also observed rough welds on the metal panel that directly contacted mung bean sprouts as they fell off the conveyor belt into the rinse water basin.
These conditions make proper cleaning and sanitization of the conveyor belt difficult. This conveyor belt transports mung bean sprouts to a rinse basin before they are placed into final packaging.
5. Your required records were not reviewed, dated, and signed by a supervisor or responsible party within a reasonable time after the records are made, as required by 21 CFR 112.161(b).
Specifically, a review of your SSIW testing records, from April 1, 2025, through October 3, 2025, which are required under 21 CFR 112.150(b)(4)], revealed they were not reviewed, signed, and dated by a supervisor or responsible party.
This is a repeat observation from the previous FDA inspection.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
In addition, we offer the following comments:
After you received a positive E. coli O157:H7 finding in an SSIW sample, you stated that you collected another sample from the same bin on August 22, 2025, which tested negative. However, this additional test does not indicate that the SSIW was not contaminated with E. coli O157:H7 because it was conducted using a second sample from the same production batch, rather than on the same enrichment sample that resulted in the presumptive positive from the screening test.
A review of your SSIW testing records, from April 1, 2025, through October 3, 2025, which are required under 21 CFR 112.150(b)(4), revealed that your firm does not maintain records linking each mung bean sprout production batch identification with the seed lots used to produce that production batch. 21 CFR 112.161(a)(1)(iii) requires your records include an adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record. Seed lot documentation will allow you to effectively correlate positive test results with the seeds that might have been the contamination source.
On October 8, 2025, employees were observed touching multiple non-food contact surfaces including a broom, black plastic pallet on the ground, scale, conveyor belt, garbage can handles, and electrical cords and then returned to harvesting, rinsing, and packaging mung beans without changing their gloves. 21 CFR 112.32 requires you to ensure that personnel who may contact produce or food contact surfaces use hygienic practices to protect against contamination of produce.
On October 7, 2025, after cleaning and sanitizing operations were completed, mung bean sprouts and sprout pieces were found between the moving parts of the white conveyor belt, a direct food contact surface, used to transport sprouts from the rinse basin to the hand-packaging area. This equipment was not cleaned or sanitized again before being used to convey, mung bean sprouts on October 8, 2025. Please note that 21 CFR 112.123(d)(1) requires you to inspect, maintain and clean and, when necessary and appropriate, sanitize food contact surfaces as frequently as reasonably necessary to protect against contamination of produce. Further 21 CFR 112.140(b) requires you to establish and keep documentation of the date and method of cleaning and sanitizing of equipment
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Rochelle R. Blair, Compliance Officer, Human Foods Program, Food and Drug Administration 5001 Campus Drive, College Park, MD 20740, or electronically to producefarminspection@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Rochelle R. Blair at (949) 608-4496 or at producefarminspection@fda.hhs.gov.
Sincerely,
/S/
Maria S. Knirk, JD, MBA
Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
U.S. Food and Drug Administration
No comments:
Post a Comment