As part of its enforcements, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.
Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Marathon Ventures, Inc.
Bellevue, NE
The Food and Drug Administration sent a warning letter dated Oct. 17, 2019, to Larsen and Sortino, co-owners of Marathon Ventures, Inc.
During an inspection from May 20, to June 4, 2019, FDA inspectors found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117. The FDA also collected environmental samples from various areas in Marathon Ventures, Inc. processing facility and found the presence of Listeria monocytogenes. The warning letters says that, “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 response to these deviations, the FDA issued an FDA-483, Inspectional Observations that lists deviations observed at the facility.
At the time the warning letter was sent, Marathon Ventures, Inc. had provided a written response outlining the corrective actions that they took in response to the inspection’s findings. The FDA responded in the letter, saying, “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.”
The violations noted by the FDA and their response to Marathon Ventures, Inc. corrective actions include:
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 (redacted) step, such as at the “(redacted),” “(redacted),” and “(redacted)” 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 (redacted)” with a sanitation preventive control at the “(redacted), (redacted)” steps. You also state, “cross- contamination is not identified as a hazard requiring a preventive control at these steps” (i.e., “(redacted)”) “because we have modified our procedures to (redacted).” However, implementing a (redacted) 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.”
b. “On (redacted) 2018, you produced almonds and then on (redacted), 2018, you produced cashews. On (redacted), an employee found and removed almonds present along with cashews while cashews were running on Nut Roaster (redacted). Another employee observed more almonds when the cashew product went to tumbling, and almonds were attempted to be (redacted) before processing continued and the cashew product was distributed. Although your firm stated during the inspection that you conduct wet cleaning (redacted), your “Sanitation Preventive Control,” issued 3/20/2019, indicates several circumstances when “limited wet cleaning procedures” are to be followed, which do not include (redacted).”
“Your responses indicate that you have updated your “Sanitation Preventive Control” procedure to include instructions on performing a limited wet cleaning (redacted) when (redacted). 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 “(redacted).” In addition, your procedure states that “(redacted).” However, on the following dates, a (redacted) result occurred, and you do not have records documenting that (redacted) of the equipment occurred prior to use:”
- “4/18/2019: the (redacted)”
- “4/29/2019: the (redacted) and Baking pans (redacted)’
“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 (redacted), to confirm there has been no recontamination after sanitation.” You also state that the “procedure also requires (redacted). This data then is (redacted).” 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 “(redacted).” 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 (redacted) of the Nut Roaster (redacted), where almonds (Item No. (redacted), Lot No.(redacted)) 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. (redacted), Lot No. (redacted)).”
“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 (redacted) sanitizer is (redacted), and per the manufacturer’s directions, the concentration should be between “(redacted) active solution.” However, the sanitizer concentration in the (redacted) was found to be at 100 ppm. Additionally, unlabeled bottles, located in the wash bay and kitchen, filled from your (redacted) 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 (redacted) 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 (redacted) 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.”
At the time the warning letter was sent, Marathon Ventures, Inc. had provided a written response outlining the corrective actions that they took in response to the inspection’s findings. The FDA responded in the letter, saying, “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.”
A complete list of the violations and their response to Marathon Ventures, Inc. corrective actions can be found in the FDA’s warning letter.
About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any of the recalled products and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.
Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop.
Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses.
Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.
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