- Chicago Indoor Garden, Inc.
- Issuing Office:
- Chicago District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Chicago District|
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
March 25, 2016
DELIVERD VIA UPS NEXT DAY
Mr. Brian P. Gorman
Chicago Indoor Garden
4459 Division St.
Chicago, IL 60651
Dear Mr. Gorman:
The United States Food and Drug Administration (FDA) conducted an inspection of your sprouting operation, Chicago Indoor Garden, located at 4459 Division St., Chicago, IL 60651, on May 11, 2015 through May 14, 2015. During the inspection, we documented insanitary conditions and practices that render your green sprouts, wheatgrass, sunflower greens, pea shoots, and sprouted beans 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. You can find the Act and its implementing regulations on the internet through links on the FDA web page at www.fda.gov
At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your sprouting operation at the time of the inspection. Your firm submitted corrective actions dated May, 28, 2015, relative to the FDA-483 findings. The following conditions and practices render your food adulterated under Section 402(a)(4) of the FDCA and have not been adequately addressed:
1. Our investigators observed the following pest activity and other evidence of pests in your building:
a. Apparent dry rodent excreta pellets throughout your sprouting operation including areas under dry storage racking where bags of seeds are stored.
b. Insect-like bore hole on a bag of buckwheat seeds stored on the seed storage rack.
c. Live Indian meal moth-like insects in the seed starting area and dry storage warehouse.
d. Live fungal gnat-like insects on the blades of wheatgrass.
e. Dead fungal fly-like insects, too numerous to count, were on lights, light shields and support structures throughout the growing table area in the table room.
2. Our investigator observed an employee repeatedly wiping their nose with a gloved hand and then returning to packaging finished red clover sprouts without washing or changing the gloves or washing their hands.
3. Our investigators observed unprotected glass lights in the following locations: directly over growing wheatgrass.
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your sprouting operation. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction.
We also have the following comments:
Our investigator observed that your firm soaks all seeds used to grow ready-to-eat green sprouts, wheatgrass, sunflower greens, pea shoots and beans (b)(4)
without sanitizing chemicals or antimicrobial treatment. This is a repeat observation that was also documented during the March 8 - 29, 2011, and February 21 - 28, 2012 inspections. On May 25, 2011 you participated in a regulatory meeting with FDA where your written response to the FDA-483 items were discussed, including your statement that you would (b)(4)
FDA’s Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds, (located online at http://www.fda.gov/food/guidanceregulation/ucm120244.htm
), recommends treating seeds for sprouting with one or more treatments (such as 20,000 ppm calcium hypochlorite) that have been approved for reduction of pathogens in seeds or sprouts.
2. Condensate was observed from the evaporator unit actively dripping directly over uncovered bins of red radish sprouts in your walk-in cooler. We recommend that you take appropriate steps to protect your food from potential contamination from building surfaces through condensation or drip from these or other surfaces.
3. Additional information on recommended handling and controls for sprouting can be found in our Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production (located online at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/produceplantproducts/ucm120246.htm), dated October 27, 1999. Also, the University of California at Davis, in cooperation with FDA, developed a series of online videos related to sprout safety that can be found at: http://postharvest.ucdavis.edu/libraries/video/. The documents and online videos are designed to assist you in complying with the Act. We also recommend that you review FDA’s recently issued final rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” 21 CFR Part 112, available at http://184.108.40.206/cgi-bin/text-idx?SID=b37a2c0de4d3a2a8aea58187fba8b7b7&mc=true&node=pt21.2.112&rgn=div5
(see also 80 FR 74354 (Nov. 27, 2015)).
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. You should include in your response documentation such as photographs of correction, work orders for equipment repair, and related sanitation corrective actions (e.g., implementation of an effective pest control program to monitor for pests or rodents, improvements to your cleaning and sanitation program for your equipment, etc.), or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Lauren Crivellone, Compliance Officer, 550 W. Jackson Blvd., Suite 1500, Chicago, IL 60661. Refer to the unique CMS number 469775 when replying. If you have questions regarding any issues in this letter, please contact Ms. Crivellone at (312) 596-4157 or Lauren.Crivellone@fda.hhs.gov
William R. Weissinger