- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameJohn S. Larsen/Michael P. Sortino
- Marathon Ventures, Inc.
901 Fort Crook Rd N
Bellevue, NE 68005-4335
- Issuing Office:
- Office of Human and Animal Food- West Division II
8050 Marshall Drive - Suite 205
Lenexa, KS 66214-1524
October 17, 2019
CMS Case #585719
Dear Messrs. Larsen and Sortino:
The United States Food & Drug Administration (FDA) inspected your Ready-to-Eat (RTE) nuts and snack manufacturing facility, located at 901 Fort Crook Rd N, Bellevue, NE 68005 from May 20, 2019 to June 4, 2019. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that the nuts and snack mixes manufactured in your facility 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. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.
FDA’s inspection resulted in an issuance of a FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. We received your firm’s responses to the FDA-483 sent via email on June 27, July 12, July 31, and August 8, 2019, in which you included a description of the corrective actions you have taken and documentation; including an updated hazard analysis, updated sanitation procedures, updated environmental monitoring procedures, employee training records, and a roof repair contract. We address your responses below.
We found the following significant violations:
Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117, Subpart C)
1. Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a)(1). Specifically, your hazard analysis does not identify the hazard of recontamination with environmental pathogens at all steps where ready-to-eat (RTE) food is stored and processed while exposed to the environment in your facility after the (b)(4) step, such as at the “(b)(4),” “(b)(4),” and “(b)(4)” steps.
Your responses state that you updated your hazard analysis for “Nuts, Seeds, Snack Mixes and Toppings” to address “the hazards of cross-contamination and environmental pathogen recontamination after (b)(4)” with a sanitation preventive control at the “(b)(4), (b)(4)” steps. You also state, “cross- contamination is not identified as a hazard requiring a preventive control at these steps” (i.e., “(b)(4)”) “because we have modified our procedures to (b)(4).” However, implementing a (b)(4) policy as a sanitation prerequisite program is not adequate to control recontamination with environmental pathogens, especially when you have records of roof leaks throughout your facility since 2016, and L. monocytogenes has been found in your processing environment.
2. You did not identify and implement sanitation preventive controls to provide assurances that any hazards requiring a preventive control (i.e., recontamination with environmental pathogens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the FD&C Act, as required by 21 CFR 117.135(a)(1) and (c)(3), as evidenced by the following:
a. From April 2019 to May 2019, you found five (5) environmental samples positive for L. monocytogenes in the environment in Zone 3, including areas within your RTE production area where RTE food is exposed to the environment. In addition, FDA laboratory analysis of environmental sample #1088400 collected at your facility on May 21, 2019, revealed that one (1) environmental swab in Zone 3 was positive for L. monocytogenes.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw material, humans or equipment. Consuming foods contaminated with L. monocytogenes 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, and its tendency to affect individual with underlying conditions. Without proper controls, L. monocytogenes can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism can grow and survive and to take such corrective actions as necessary to eradicate the organism. Continued findings of L monocytogenes in your environment are further evidence that additional measures may be needed in your facility to address L. monocytogenes.
b. On (b)(4) 2018, you produced almonds and then on (b)(4), 2018, you produced cashews. On (b)(4), an employee found and removed almonds present along with cashews while cashews were running on Nut Roaster (b)(4). Another employee observed more almonds when the cashew product went to tumbling, and almonds were attempted to be (b)(4) before processing continued and the cashew product was distributed. Although your firm stated during the inspection that you conduct wet cleaning (b)(4), your “Sanitation Preventive Control,” issued 3/20/2019, indicates several circumstances when “limited wet cleaning procedures” are to be followed, which do not include (b)(4).
Your responses indicate that you have updated your “Sanitation Preventive Control” procedure to include instructions on performing a limited wet cleaning (b)(4) when (b)(4). FDA recommends that you ensure the area is completely dried after the wet cleaning to prevent Salmonella contamination in your nut products. We will evaluate the effectiveness of your program during a future inspection.
3. You did not document all corrective actions in records, as required by 21 CFR 117.150(d).
a. Your written corrective action procedure for your “Sanitation Preventive Control,” issued 3/20/2019, states that “(b)(4).” In addition, your procedure states that “(b)(4).” However, on the following dates, a (b)(4) result occurred, and you do not have records documenting that (b)(4) of the equipment occurred prior to use:
• 4/18/2019: the (b)(4)
• 4/29/2019: the (b)(4) and Baking pans (b)(4)
Your responses indicate that you have established a new sanitation monitoring program and a new recordkeeping system. You state that the “new procedure requires that the (b)(4), to confirm there has been no recontamination after sanitation.” You also state that the “procedure also requires (b)(4). This data then is (b)(4).” We will evaluate the effectiveness of your program during a future inspection.
b. Your written corrective action procedure for your “Environmental Microbial Sampling SOP,” issued 3/19/2019, states that “(b)(4).” However, between April 2019 and May 2019, you identified five positive environmental samples of L. monocytogenes, and you do not have records to show that you conducted an investigation of the potential source or cause of contamination.
Your responses indicate that state that although you did not document the root cause of the positive L. monocytogenes samples, you had performed a root cause analysis for each sample that tested positive for L. monocytogenes. However, your written response and “Environmental Microbial Sampling SOP,” issued 7/12/2019, do not address how you will ensure employees will document the corrective actions and investigations when there are positive environmental test results in the future. We will evaluate the effectiveness of your program during a future inspection.
Current Good Manufacturing Practice (21 CFR 117, Subpart B)
1. You did not keep your building, fixtures, and other physical facilities of the plant in adequate repair to prevent food from becoming adulterated. Further, you did not clean and sanitize utensils and equipment in a manner that protects against allergen cross- contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). Specifically, our investigator observed the following:
a. During the inspection, your firm experienced six new roof leaks, including a water leak on top of the (b)(4) of the Nut Roaster (b)(4), where almonds (Item No. (b)(4), Lot No.(b)(4)) were being roasted, and a water leak in your warehouse where RTE finished product and ingredients were being stored. Specifically, water was observed pooled on top of the permeable sack containing RTE roasted almonds (Item No. (b)(4), Lot No. (b)(4)).
Your responses state that you have updated your procedure to control potential contamination from roof leaks and that you have a contract in place to repair the roof. We will verify the adequacy of your corrective actions during a future inspection.
b. Your established concentration limit for (b)(4) sanitizer is (b)(4), and per the manufacturer’s directions, the concentration should be between “(b)(4) active solution.” However, the sanitizer concentration in the (b)(4) was found to be at 100 ppm. Additionally, unlabeled bottles, located in the wash bay and kitchen, filled from your (b)(4) and used by firm employees to sanitize equipment including food contact surfaces, were found to be at a concentration of 100 ppm.
Your responses state that you have modified your procedures to ensure proper concentrations are maintained, including updating your “Sanitizer Concentration Log.” We will verify the adequacy of your corrective actions during a future inspection.
2. You did not maintain gloves in an intact, clean, and sanitary condition, as required by 21 CFR 117.10(b)(5). Specifically, our investigator observed the following:
a. On 5/20/2019, an employee at the tumbler touched his smock, then placed his entire arm into the tumbler to un-clump product inside the equipment, using the same gloves.
b. On 5/22/2019, employees on the Nut Roaster (b)(4) handled corrugated cardboard used for finished product packaging and then touched the interior of plastic bags used for holding roasted sunflower seeds, a food contact surface, while wearing the same gloves.
c. On 5/22/2019, employees touched non-food contact surfaces during packaging and subsequently handled glazed and toasted walnuts, while wearing the same gloves.
d. On 5/31/2019, an employee turned off the tumbler at the control panel and then dumped a (b)(4) of almonds into the tumbler, wearing the same gloves. Thereafter, the employee turned the tumbler back on and off again at the control panel, and then opened the bottom of the tumbler to allow product in the tumbler to flow into the bin below while coming into contact with the RTE food, still wearing the same gloves.
Your written responses indicate that you have revised your procedure for handwashing and glove usage. Also, you indicate that you will use (b)(4) when production is in process to allow production employees to touch the plastic without requiring a glove change. Your procedure, “Program Overview, Processing Practices,” states that when (b)(4), they will be changed out at a minimum (b)(4) and (b)(4). We will evaluate the effectiveness of your program during a future inspection.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
Section 743 of the Act, (21 USC 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 non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means 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 USC 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-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections.
If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: Kara L. Roden, Compliance Officer, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have questions regarding any issues in this letter, please contact Ms. Roden at 913-495-5121 or Kara.Roden@fda.hhs.gov.
Cheryl A. Bigham
Program Division Director
Human and Animal Foods Division West II