Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:

Recipient Name

Mr. Brian P. Gorman

Chicago Indoor Garden, Inc.

4459 West Division Street
Chicago, IL 60651
United States

Issuing Office:
Division of Human and Animal Food Operations East VI

United States

WARNING LETTER
FY2020-HAFE-WL-04

July 30, 2020

Dear Mr. Nolan:

The U.S. Food and Drug Administration (FDA or we) inspected your sprouting operation located at 4459 W. Division St., Chicago, IL 60651, from February 28, 2020, through March 31, 2020. FDA conducted this inspection because sprouts grown at your sprouting operation were linked by epidemiological and traceback information to an outbreak of human infections with Shiga toxin-producing Escherichia coli O103 (E. coli O103). During the inspection, FDA collected samples of your sprouts. FDA laboratory analysis of the samples identified the presence of E. coli O103 in red clover sprouts collected from your operation.

Based on these findings, we have determined that your red clover sprout products are adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. §342(a)(1)] in that your red clover sprouts bear or contain a poisonous or deleterious substance which may render them injurious to health.

During the inspection, FDA investigators also documented serious violations, described below, 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 these findings, we have determined that your sprout products 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 were 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 requirements under Section 419 of the Act [21 U.S.C. § 350h] 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 internet links in FDA's home page at http://www.fda.gov.

The inspection resulted in FDA's issuance of a Form FDA-483, Inspectional Observations, listing the violations found at your sprouting operation during our inspection. We acknowledge receipt of your response on April 15, 2020, to the FDA-483, which included corrective actions you have implemented or plan to implement. We address your response below.

Pathogen Findings
Shiga toxin-producing E. coli O103 is a pathogenic bacterium that can cause serious illness in humans, including diarrhea, often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure call Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. This condition can lead to serious kidney damage and death.

On March 3, 2020, FDA collected a sample of red clover sprouts (1119371) from your sprouting operation. The laboratory analysis yielded E. coli O103 isolated from one of ten subs. Whole genome sequencing (WGS) analysis was conducted on the two E. coli O103 isolates obtained from the positive product sample collected during our inspection on March 3, 2020. The WGS analysis determined that the two isolates from sample 1119371 were genetically identical to each other and to isolates from the outbreak (2002IAEXW-1 and 1912IAEXW-1).

We received your written response on April 15, 2020, outlining the corrective actions that you have taken in response to the product sample findings; however, we are unable to evaluate the adequacy of your corrective actions. We acknowledge that you agreed on March 16, 2020, to recall all products containing red clover sprouts. We also acknowledge that you stated that you stopped production of red clover sprouts, ordered seed from a different supplier, conducted a root cause analysis, had the seed's spent irrigation water tested for E. coli O103, and deep cleaned some of the equipment that you use to grow your sprouts in. We will evaluate the adequacy of your corrective actions at our next inspection.

Produce Safety Regulation Violations
During the inspection, FDA investigators observed the following significant violation of the Produce Safety regulation, 21 CFR Part 112:

1. You did not discontinue the use of all seeds from a lot which you knew or had reason to believe may have been contaminated with a pathogen, and you did not ensure that sprouts grown from that lot of seeds did not enter commerce as required by 21 CFR 112.142(b)(1), . Specifically, at the end of December and beginning of January 2020, your operation received communication from your seed supplier, indicating that sprouts grown from clover seed lot (b)(4) had been voluntarily recalled by another sprouting operation, and that the seed supplier was waiting to receive test results to determine whether lot (b)(4) was contaminated with pathogens. In December 2019, you placed that lot on hold. However, in January 2020, without further communication from your seed supplier, you resumed sprout production using lot (b)(4) to grow sprouts which were sold to your customers.

We acknowledge your written response received April 15, 2020; however, we are unable to evaluate the adequacy of your corrective actions. In your response, you stated that decisions made about "questionable" seed would be discussed with the owner and all management before any decisions are made about that seed. We will evaluate the adequacy of your corrective actions at our next inspection.

2. You did not inspect, maintain, and clean, and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce, as required by 21 CFR 112.123(d)(1). Specifically, on March 10, 2020, and March 12, 2020, after our investigator observed an employee cleaning sprout drums used in the growing of sprouts, the investigator observed that those sprout drums contained yellowish-brown residues on their walls, and the screw heads of the drums had black residues on them.

We acknowledge your written response received April 15, 2020; however, we are unable to evaluate the adequacy of your response. Your response states that you have updated sanitation monitoring checklists and updated the SOP for drum cleaning. However, your response did not address the sanitizers used for cleaning and the instructions for use and did not provide a list of all equipment that will be disassembled, cleaned, and sanitized. We will evaluate the adequacy of your corrective actions at our next inspection.

This letter is not intended to be an all-inclusive list of the violations at your operation or in connection with your products. You are responsible for ensuring that your operation operates in compliance with the Act and all implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure and/or injunction.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. 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 Lauren Crivellone, Compliance Officer, HAFE6. If you have questions regarding this letter, please contact Compliance Officer at (312) 596-4157 or via e-mail at: Lauren.Crivellone@fda.hhs.gov.

Sincerely,
/S/

William R. Weissinger
Program Division Director,
Office of Human and Animal Food Operations,
East Division VI