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SK Food Group MARCS-CMS 515676 —

Recipient Name
Mr. Jakob Loseke
SK Food Group

5555 Quail Manor Court, Suite 100
Reno, NV 89511
United States

Issuing Office:
San Francisco District Office

United States



Black HHS-Blue FDA Logo



1431 Harbor Bay Parkway
Alameda, CA 94502-7070 


March 13, 2017
Mr. Jakob Loseke
Vice President for U.S. Operations and Plant Manager
SK Food Group, Inc.
5555 Quail Manor Court, Suite 100
Reno, NV 89511-1804
Dear Mr. Jakob Loseke:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) sandwich, wrap and flatbread manufacturing facility located at 5555 Quail Manor Court, Suite 100, Reno, Nevada from November 15, 2016 to November 17, 2016. During our inspection, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental samples (i.e., swabs) identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110)1. Therefore, we have determined that your RTE sandwich, wrap and flatbread 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 have been 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 http://www.fda.gov.
Presence of L. monocytogenes
FDA’s laboratory analysis of the environmental samples collected on November 15 and 16, 2016, confirmed that three (3) of the one-hundred and forty seven (147) environmental swabs were positive for L. monocytogenes. Specifically,
-     Two (2) environmental swabs were collected from locations that were in areas adjacent to food contact surfaces. The samples were collected from the floor and floor drain in the Dishwashing Room.
-     One (1) environmental swab was collected from the second drainage area in the Assembly Room.
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 equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical 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.
The referenced environmental samples were further analyzed using Whole Genome Sequencing (WGS). 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. WGS analysis was conducted on the three (3) L. monocytogenes isolates obtained from the FDA environmental samples collected on November 15 and 16, 2016. The WGS analysis shows that the 2 isolates collected on November 16, 2016, belong to the same strain of L. monocytogenes, suggesting that these 2 isolates found in the environment of the facility originated from the same source of contamination. The third isolate (collected on November 15, 2016) was a genetically distinct strain and was not close to any other isolate in the WGS database.
The presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility generally and potentially on your processing equipment in order to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires expert knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to eliminate this pathogen. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take necessary corrective actions to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
Furthermore, FDA laboratory analyses of samples INV 932597 and INV 932598 also isolated six (6) swabs with non-pathogenic Listeria species including Listeria innocua, Listeria seeligeri and Listeria welshimeri.  Listeria innocua, Listeria seeligeri and Listeria welshimeri. These positive swabs were found on non-food contact surfaces including the floor in the Dishwashing and Mezzanine Rooms and on direct food contact surfaces, like the conveyer belt, where you manufacture RTE food products. The presence of non-pathogenic Listeria species is indicative of insanitation and conditions that are suitable for the survival and/or growth of the pathogen L. monocytogenes.
We received your response on December 20, 2016, outlining the corrective actions you have taken in response to the L. monocytogenes environmental sample findings. We acknowledge that you have revised your training and environmental monitoring programs as well as sanitation procedures; however your response does not demonstrate that you have taken steps to eliminate L. monocytogenes from your processing environment or effectively prevent it from contaminating finished products you may manufacture in the future. We recommend that you review FDA’s draft guidance for industry titled “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing your Listeria control plan. The draft guidance can be found at:
-     Additionally, of concern during the inspection was the observation by the FDA investigators that firm failed to ensure that cleaning and sanitizing of utensils and equipment was conducted in a manner that protected against contamination of food, food-contact surfaces, or food- packaging materials, a requirement of 21 CFR Part 110.35(a). Specifically, our investigators observed employees using a high pressure hose to clean a bread slicing machine in the dishwashing room. The hose splashed water from the dirty machine onto a pallet holding clean plastic bins and lids, used to carry sandwich components that include cheese, ham, bacon and egg to various RTE production lines. L. monocytogenes was isolated from the dishwashing room floor in close proximity to the clean plastic bins.
This letter may not list all the violations at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You are responsible for ensuring that your products are in compliance with the Act and all applicable FDA regulations. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-inspection fees [21 U.S.C § 379j-31(a)(2)(B)]. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related cost.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these violations. You may wish to include in your response documentation such as labels, and photographs of corrections your firm has taken or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations.
Please send your reply to the Food and Drug Administration, attention:
Lawton W. Lum, Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference Case number 515676
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-6737.
Sincerely Yours,
Darla R. Bracy
Acting District Director
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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