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  5. Jeni's Splendid Ice Creams, LLC - 492668 - 08/09/2016
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Jeni's Splendid Ice Creams, LLC MARCS-CMS 492668 —

Jeni's Splendid Ice Creams, LLC

United States

Issuing Office:
Cincinnati District Office

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Cincinnati District Office  
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761


August 9, 2016
John Lowe, IV
President and CEO
Jeni’s Splendid Ice Creams, LLC
401 N. Front Street, Suite 300
Columbus, OH 43215
Warning Letter
Dear Mr. Lowe:
The U.S. Food and Drug Administration (FDA) inspected your frozen flavor base manufacturing facility located at 909 Michigan Avenue, Columbus, Ohio on January 25, 2016 through February 9, 2016. During the inspection, FDA collected environmental samples from various areas in your processing facility including areas that are in close proximity to food and food contact surfaces. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA investigators observed violations of Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110)[1]. Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we determined that your frozen flavor base 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 been rendered injurious to health. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
The inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s responses dated March 2, 2016, April 14, 2016, and April 27, 2016.
Pathogen Findings
FDA’s laboratory analysis of the environmental samples collected on January 26, 2016, confirmed that two (2) of seventy five (75) environmental swabs were positive for L. monocytogenes. Specifically, these positive samples were taken from:
-    The floor of the prep room adjacent to the open entryway to the dish room and approximately 9 feet from the prep table where your firm was processing and packaging Intelligentsia Black Cat Espresso Base.
-    The floor of the wash room around a drain, which is approximately 2 feet from the three-compartment sink used to wash, rinse, and sanitize equipment parts, utensils, and containers used in production, approximately 3 feet from the shelving unit on which the above items were stored after cleaning, and approximately 3 feet from the (b)(4) used to wash equipment parts used in production.
Furthermore, this was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for L. monocytogenes. Environmental swabs collected during our April 20, 2015 – April 30, 2015 inspection revealed L. monocytogenes in twenty (20) locations within your facility. This inspection was initiated due to a positive finding of L. monocytogenes in a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015. Of the twenty (20) positive samples found during our April 2015 inspection, a number of samples were located in areas adjacent to food contact surfaces including: areas of the (b)(4) used to fill pints of ice cream and areas of the black plastic carts used to move product around the prep and production rooms. 
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or the equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming this contaminated food can lead to a severe, sometimes life-threatening illness called listeriosis, a  foodborne illness, which is a major public health concern, due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.
Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from a FDA environmental sample collected on January 26, 2016, twenty (20) L. monocytogenes isolates obtained from a FDA environmental sample collected on April 21, 2015, and two (2) L. monocytogenes isolates obtained from a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome.  The WGS phylogenetic analysis found that there is one (1) strain of L. monocytogenes present in your facility containing isolates that have been found over a period of time. Specifically, two (2) of the environmental isolates collected January 26, 2016, twenty (20) of the environmental isolates collected April 21, 2015, and two (2) of the finished product isolates from the sample of ice cream collected in April 2015, were identical by WGS analysis.
The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since 2015. The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
FDA acknowledges that after our April 2015 findings, your firm took extensive corrective actions including, hiring a sanitation consultant and voluntarily shutting down production on certain dates to deep clean and sanitize your facility. Additionally, FDA acknowledges that in 2015 your firm conducted a voluntary recall of your ice cream, frozen yogurt, sorbet, and ice cream sandwiches for all flavors and containers. Additionally, we acknowledge the changes in your production flow, where your firm no longer manufactures finished ice cream, frozen yogurt, or sorbet on-site. Instead, your firm manufactures frozen flavor bases and ships these bases to co-manufacturers for use in the production of your firm’s brand of finished ice cream and frozen yogurt.
cGMP Violations
Additionally, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1.    Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food-contact surfaces, as required by 21 CFR Part 110.20(b)(6).  Specifically, during the manufacture of Buttermilk Yogurt Base, Brambleberry Crisp Base, and Intelligentsia Black Cat Espresso Base, our investigator observed a dust-like material adhering to the guard over the fan on the west end of the underside of the ceiling-mounted cooling unit located in the dish room, where containers, equipment parts, and utensils used in production are washed, rinsed, sanitized, and stored. This is a repeat observation from our April 2015 inspection  where heavy accumulation of apparent dust and dirt was observed adhering to the guards over the two fans on the evaporator unit located in the dish room where tubs, equipment parts, and utensils used in production were washed, rinsed, sanitized, and stored.
Your firm’s response indicates that you have updated the cleaning procedure in your Master Sanitation Schedule and included air handling units as an environmental sampling site. We acknowledge these corrective actions and will ascertain the adequacy of your corrective action during our next inspection.     
2.    Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR Part 110.80. Specifically, our investigator observed an employee in the prep room placing  “skinned” bags of sugar on a cart in the prep room, then moving these bags beside a prep table where they were picked up and manually poured from the bags into clear plastic containers such that the outside of the sugar bags came into direct contact with the inner food contact surface of the plastic containers. This is a repeat observation from our April 2015 inspection, where a bag of cocoa powder was observed being handled by an employee in a similar manner. 
Your firm’s response indicates that you have updated your Traffic Flow SOP to address the flow of people and materials; added a new SOP to provide additional details and clarify requirements for ingredient transfer;  and conducted and documented an employee training on the updated SOP on January 29, 2016 to February 1, 2016. Furthermore, to validate the effectiveness of the training a Manager audited compliance to the new procedure and monitored all shifts in the operation. We acknowledge these corrective actions and will ascertain the adequacy of your corrective action during our next inspection.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliances materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related cost.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700 Ext. 2163.
Steven B. Barber
District Director
Cincinnati District

[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.

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