Food Safety News reported that ready-to-eat, smoked fish and fishery products produced by Michel Cordon Bleu Inc. in Los Angeles from such raw fish as Florida salmon and Idaho trout and sold to restaurants, retailers, hotels and cruise ships are not safe for human consumption, according to a federal court action.

The U.S. Food and Drug Administration has found the company’s fish and fishery products are adulterated as defined y federal law. Consequently, the U.S. Department of Justice (DOJ) this week filed a civil action against both Michel Cordon Bleu Inc. and owner Michel G. Blanchet.

DOJ’s Consumer Protection Branch asked the U.S. District Court for the Central District of California for a permanent injunction to shut down Bleu’s operations at 3625 South Western Avenue in Los Angeles.

In an 11-page complaint, DOJ attorneys say the seafood processor has a history of violating federal food safety regulations that began in 1998 and continued through July 5 to Aug. 2, 2016, its most recent FDA inspection.

Among the Form FDA-483 inspection observations noted a year ago were:

  • Failure to manufacture, package and store food under conditions and controls necessary to minimize the potential for microorganism growth and contamination, including Listeria monocytogenes;
  • Failure to monitor the sanitation conditions and practices, resulting in findings of Listeria monocytogenes in the company’s processing areas;
  • Failure to develop the verification procedures and frequencies listed in the HAACP (Hazard Analysis and Critical Control Point) plan by federal regulation to ensure that the HACCP plan is adequate to control food safety hazards, and is implemented efficiently; and
  • Failure to implement the monitoring and verification procedures listed in the HACCP plan.

FDA found “deficient cleaning and sanitation practices” at the Bleu facility has led to the contamination of food preparation surfaces with pathogenic bacteria. Strict in-plant measures are necessary to control the spread of Listeria monocytogenes in the seafood processing plant and to protect human health.

FDA ‘s environmental sampling showed Listeria monocytogenes contamination exists in multiple locations throughout the Bleu facility.

The complaint charges Bleu with a “history of non-compliance.” FDA has tried to bring the company into compliance with inspections, regulatory meetings, and warning letters without successs.

At a 2005 regulatory meeting, the company said it was committed to building a “culture of compliance,” promising to adhere to a HACCP plan. It’s not, however, lived up to that promise.

Bleu prepares, processes, packs, holds and distributes refrigerated vacuum-packed, ready-to-eat cured, cold and hot smoked fish and fishery products including smoked salmon, trout, and sturgeon. Distributors sell most of the product.

DOJ says Bleu’s seafood products present a hazard to human health because of the potential for contamination from Clostridium Botulinum (C. bot) and Listeria monocytogenes (L. mono).

The complaint says Bleu and Blanchet, who is both the owner and company president, did not respond to FDA’s many concerns about the facility’s problems.

DOJ wants U.S. District Judge R. Gary Klausner to issue a permanent injunction ordering Blue to “cease receiving, preparing, processing, packing, labeling, holding, and distributing food at or from the facility or any other location nor or in the future.” The government also wants the judge to authorize FDA to inspect the plant and all the company’s records.

DOJ filed the civil action on Oct. 3, and the defendants have not yet responded Discovery motions in the Central District are heard by magistrate judges. Assigned to this case is federal Magistrate Judge Alka Sagar.

While government action to permanently enjoin a company from operating is rare, seafood processors are frequently targets of FDA warning letters for failure to take corrective actions after inspections.

Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.

The following products are being recalled by the firm.

  • 1 lb. bags of soybean sprouts in clear plastic bags labeled “Good Seed Soy Bean Sprouts” “Keep Refrigerated” with a UPC Code of 21111 10035, produced on or after May 1, 2017.
  • 2 lb. bags of soybean sprouts in clear plastic bags labeled “Good Seed Soy Bean Sprouts” “Keep Refrigerated” with a UPC Code of 21112 58772, produced on or after May 1, 2017.
  • 10 lb. bags of soybean sprouts in black plastic bags labeled with a sticker “Good Seed Soy Bean Sprouts” produced on or after May 1, 2017.

These items were distributed to retail stores in Virginia, Maryland and New Jersey.

The potential for contamination was noted after routine surveillance sampling by the Food Safety Program of the Virginia Department of Agriculture and Consumer Services (VDACS). Subsequent testing by the Virginia Division of Consolidated Laboratory Services revealed the presence of Listeria monocytogenes in sampled product. No illnesses have been reported to date.

033feb5Here is the Vulto Creamery’s FDA 483 Inspection Report

OBSERVATION 1

Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Specifically:

  • A finished product sample of your firm’s Ouleout soft raw milk cheese product bearing lot #617 was analyzed by an FDA laboratory and found to be positive for Listeria monocytogenes, a foodbome pathogen.
  • A finished product sample of your firm’s Ouleout soft raw milk cheese product bearing lot #623, collected by the New York State Department of Agriculture and Markets in your facility on 2/28/2017 during the FDA inspection, was found to be positive for Listeria monocytogenes, a foodbome pathogen.

OBSERVATION 2

Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.

Specifically, a review of your environmental sampling test records noted the following:

  • You have conducted environmental sampling during 20 months from 7/28/2014 through 2/19/2017. Your records show 54 out of 198 results positive for Listeria spp. taken from various locations throughout your manufacturing facility, which include, but are not limited to: floor drains in the manufacturing room, wash room and cheese aging room; outside of brine tanks in the walk-in cooler; door handles to the cheese aging room, walk-in cooler and entry door; various areas of the floor in the cheese aging room; bottom of a squeegee in the cheese aging room; employee aprons; and wooden cheese rack dollies in the cheese aging room.  The most recent positive finding being a swab taken from the floor in the manufacturing room on 2/19/2017. You have not conducted an investigation to provide identification of the Listeria spp. to Genus and species and you have also failed to identify its source or point of entry/harborage in your facility.
  • A total of 10 of the 54 positive results were found on food contact surfaces between 10/30/2014 and 4/28/2015. You did not conduct microbial testing of finished products to confi1m that your finished products were not contaminated with the organism found by your environmental testing program. According to your sample records, the food contact surface locations were as follows:

o Wooden cheese aging board in cheese aging room; positive result from 10/30/2014.

o The cheese brush used to brush Ouleout and Miranda soft cheeses and two wooden

cheese aging boards in cheese aging room; positive results from 12/3/2014.

o The cheese brush used to brush Ouleout and Miranda soft cheeses and two wooden cheese aging boards in cheese aging room; positive results from 116/2015.

o Two cheese brushes used to brush the Andes and the Walton Umber hard cheeses;

positive results from 2/3/2015.

o Two cheese brushes used to brush the Andes and the Walton Umber hard cheeses;

positive results from 3/22/2015.

o A cheese brush (not specified to product); positive result from 4/28/2015.

  • You did not continue sampling food contact surfaces after 4/28/2015 to determine if Listeria spp. was still present on these surfaces representing a continued contamination risk to your cheese products.
  • Upon finding a Listeria spp. positive result on a surface, you re-cleaned and re-sanitized the area, but did not re-swab that location until a month or more later, after additional lots of cheese had been produced, to determine if your cleaning and sanitizing was effective and to dete1mine if the Listeria spp. was still present.

OBSERVATION 3

The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.

Specifically, review of your environmental sampling results across 20 months from 7/28/2014 through 2/19/2017 showed positive results for Listeria species on several food contact and non-food contact surfaces in your facility.  Per your documented corrective actions, upon getting a positive result you re- cleaned and re-sanitized the affected areas using your routine cleaning and sanitizing operations. However, when you re-sampled these locations a month or more later and tests showed repeated positive results, you did not investigate the use of a more effective method of cleaning and sanitizing.

OBSERVATION 4

Failure to store cleaned and sanitized portable equipment in a location and manner which protects food- contact surfaces from contamination.

Specifically, you were storing wood boards that have been cleaned and sanitized in your facility attic, where exposed insulation and other debris were observed.   Your ready-to-eat Hamden, Blais Blue, Andes and Walton Umber cheese products sit directly on these boards during the aging process.

Additionally, you stated that the attic gets ve1y hot during the summer months, and that it can take approximately _________ for the wood boards to completely dry.

OBSERVATION 5

Failure to take necessary precautions to protect against contamination of food and food contact surfaces with Microorganisms and foreign substances.

Specifically, on 3/1/2017 the following was observed during the manufacturing of your Walton Umber hard cheese product:

  • You and your employee were observed placing your bare hands and arms, up to your elbows, directly into the cheese making vat in order to manually break up recently formed cheese curds. Although you washed your hands, neither of you washed your lower or upper arms. Additionally, your employee was observed to have multiple cuts and abrasions on his rums, which came in direct contact with cheese curds and whey.
  • A stainless-steel ladle, used to scoop milk for pH analysis, had buildup of a mold-like substance on its inner surface. You stated you use this same ladle in the same manner during the manufacturing of all cheese products.

OBSERVATION 6

The design and materials of equipment does not allow proper cleaning and maintenance.

Specifically, a large majority of the wooden boards used for aging in the cheese aging room are of a design that does not allow them to be appropriately cleaned and sanitized.  The boards, which you stated were made from __________ have uneven surfaces, were rough cut, and have knots, frays, and splinters, which allows for the collection of moisture and debris, representing a potential harborage area for filth and microorganisms. These wooden boards come in direct contact with your aging Hamden, Blais Blue, Walton Umber and Andes ready-to-eat cheese products.

OBSERVATION 7

The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food and food-contact surfaces.

Specifically, on 3/1/2017, condensation was noted dripping from the horizontal stainless steel bar on the cheese press directly onto the food contact surface of the draining table below.  This table is used to allow molded cheese products to drain off whey.  Additionally, rust-like particles were noted in the condensation puddle on the table.

OBSERVATION 8

Employees did not sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.

Specifically, during the inspection on 3/1/2017, it was observed that you and your employee did not sanitize your hands or arms prior to using them to stir and break up the in-process Walton Umber cheese curds.

OBSERVATION 9

Failure to maintain physical facilities in repair sufficient to prevent food from becoming adulterated. Specifically, the following was observed throughout the inspection:

  • Heavy buildup of apparent rust-like substance on the white painted ve1tical supp01t bars that hold the cheese presses in place. These bars are located directly over the draining table closest to the window in the manufacturing room; flakes of this rust-like substance were observed on the top surface of the drain table where molds of cheese are set to drain.
  • Heavy buildup of apparent rust-like substance on painted white metal storage shelf in wash room. This shelf is used to store cheese molds and other equipment and utensils.
  • A heavy buildup of apparent black and green rust-like substance was noted on the cement walls in the manufacturing room and wash room. Several cleaning brushes, storage racks and cheese molds were noted to come in direct contact with these walls.  Additionally, these walls were moist from condensation.
  • Heavy buildup of rust-like and black rust-like substance on stainless steel storage shelf in walk-in cooler. This shelf was being used to hold boxes of wrapped finished cheese products.
  • A large piece of ceiling tile was missing in the cheese aging room. Uncovered, ready-to-eat cheese was being stored directly below this area.
  • The exhaust fan on the ceiling in the manufacturing room has a buildup of dirt-like and rust-like substances. This fan is directly above a stainless-steel draining table where molded cheeses are placed to drain whey.

OBSERVTION 10

Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces.

Specifically, during the inspection, the following was observed:

  • On 3/2/2017, a fan in the attic that was in operation to my cleaned and sanitized wood boards regularly used for cheese aging was noted to have dirt and dust debris buildup on the spinning arms and face of the fan. These wood boards come in direct contact with Hamden, Blais Blue, Walton Umber and Andes ready-to-eat cheese products during the aging process in the cheese aging room.
  • On 2/28/2017, a fan in the manufacturing room was noted to have a ve1y heavy buildup of unknown debris on the spinning arms and face of the fan. You stated your firm uses this fan to help by the floor in the manufacturing room after cleaning.

OBSERVATION 11

Lack of an automatic temperature alarm system for each freezer and cold storage compartment used to store food capable of supp01ting the growth of microorganisms.

Specifically, your firms cheese aging room and walk-in cooler lack an automatic temperature alarm system that would provide indication that a significant temperature change occurred. Your finished cheese products are stored in the cheese aging room.

Additionally, you stated that you do not calibrate and never have calibrated the thermometers located in the cheese aging room and walk-in cooler.

Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, throughout the inspection the following was observed:

  • The concrete floors in the manufacturing room and cheese aging room were noted to be cracked and pitted; an accumulation of moisture was noted to be stuck in the cracks and pits of the floor.
  • A buildup of apparent black rust-like substance was noted on the window sill in the wash room.
  • There is an uneven layer of concrete mortar around the _________ in the manufacturing room. There are also cracks where the mortar meets the       .
  • The door to the manufacturing room does not have a door handle, but instead has plastic packing tape covering part of the hole.
  • The walk-in cooler door does not have a door handle, but instead has a duty cloth rag plugging up the hole.
  • A heavy buildup of rust-like debris was noted on the lower part of the manufacturing room door.
  • There was buildup of a black rust-like substance on the wall between the walk-in cooler and cheese aging room.
  • A hole was noted at the bottom of the wall near· the foot bath in the packaging room
  • A black rust-like substance was observed on the ceiling in the packaging room, near· the wash room entrance.

OBSERVATION 13

Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.

Specifically, during the inspection on 2/28/2017, a long piece of sticky fly tape, heavily populated with dead insects, observed hanging directly over exposed, uncovered ready-to-eat cheese products in your cheese aging room was pointed out to you.  This fly tape was observed hanging in the cheese aging room in the same condition on 3/1/2017 and 3/7/2017.

OBSERVATION 14

Plumbing constitutes a source of contamination to equipment and utensils. Specifically, during the inspection the following was observed:

  • A hose with a nozzle on the end was directly connected to the potable water supply in the manufacturing room without a proper backflow prevention device installed. This hose is used during cleaning operations.
  • A hose with a nozzle on the end was directly connected to the potable water supply in the wash room without a proper backflow prevention device installed. This hose is used during cleaning operations.
  • The drain pipe from the 3-basin sink in the manufacturing room is approximately 2.5 inches wide. The air gap between the drain pipe and the waste funnel is only 1.5 inches, which does not provide an adequate air gap between your sink drain and waste pipe.
  • The wash room 3-basin sink does not have an air gap installed between the sink drain pipe and the waste pipe.

OBSERVATION 15

You did not submit a reportable food rep01t to FDA within 24 hours after you determined that a food was a reportable food.

Specifically, you were notified via telephone on 3/3/2017 that your firm’s Ouleout soft raw milk cheese product bearing lot #617 was found to be positive for Listeria monocytogenes, a foodbome pathogen, and that you would need to file a reportable food reported to the FDA within 24 hours.  At this present time, you still have not filed a reportable food report with the FDA.

raw-milk-01New York State Department of Agriculture and Markets Commissioner Richard A. Ball is warning consumers in Oneida County and the surrounding area not to consume unpasteurized raw milk from the Winters Grass Farm due to possible Listeria contamination. The Winters Grass Farm is located at 9104 Butler Road, Sauquoit.

A sample of the milk collected by an inspector from the department was discovered to be contaminated with Listeria monocytogenes. On March 16, 2017, the producer was notified of a preliminary positive test result. No illnesses are known at this time by the Department to be associated with this product.

20170323a_1490326479904_eng___Super_PortraitIn Canada, Wellington Dufferin Guelph Public Health is getting the word out about a Canadian Food Inspection Agency recall for a brand of guacamole that may contain listeria. On Friday, the CFIA recalled Chef Destinations, Frankly Fresh Salads, and Fresh St brands Fresh Guacamole because it may permit the growth of Listeria monocytogenes.

Anyone who purchased the products listed is asked to throw them out or return them to the store. The health unit warns that food contaminated with listeria may not look or smell spoiled but can still make you sick.

Listeria monocytogenes causes listeriosis, which can be a serious and sometimes fatal infection in young children, cancer patients, elderly people and others with weakened immune systems. Although otherwise healthy persons may suffer only short-term, flu-like symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, listeriosis can cause miscarriages and stillbirths in pregnant women.

WawonaIn 2015, the CDC reported on an outbreak and recall that occurred in 2014 – And, then a death certificate landed in my inbox.

On July 19, 2014, a packing company in California, Wawona Packing Co., voluntarily recalled certain lots of stone fruits, including whole peaches, nectarines, plums, and pluots, because of concern about contamination with Listeria monocytogenes based on internal company testing. On July 31, the recall was expanded to cover all fruit packed at their facility during June 1–July 17.

In early August 2014, a two-enzyme pulsed-field gel electrophoresis (PFGE) pattern shared by three L. monocytogenes isolates from stone fruit associated with the recall was uploaded to PulseNet, the national molecular subtyping network for foodborne disease surveillance. Four human isolates with isolation dates during the period May 8–July 8, 2014 (Illinois, Massachusetts, and South Carolina) and August 28 (Minnesota) were identified that had PFGE patterns indistinguishable from isolates from company A stone fruit.

Samples of stone fruits from Wawona Packing Co. collected after the recall yielded an additional 31 L. monocytogenes isolates, 22 of which were indistinguishable from the initial isolates by PFGE; three other PFGE patterns were identified that did not match any isolates from clinical specimens collected during May 1–August 31. Whole-genome sequencing (WGS) analysis by whole-genome multilocus sequence typing showed that isolates from the Massachusetts and Minnesota patients were highly related (<10 allele differences and <10 high-quality single nucleotide polymorphism differences) to the isolates from recalled stone fruits, whereas the Illinois and South Carolina isolates were not.

A review of the standardized Listeria Initiative exposure questionnaire for the Massachusetts patient showed that organic nectarine consumption was recorded, although the form does not specifically ask about stone fruit consumption. A subsequent interview using a questionnaire with questions about stone fruits indicated that the patient consumed nectarines and peaches purchased from stores that sold Wawona Packing Co. stone fruit. Traceback using receipts and shopper card data indicated the patient’s family purchased recalled fruit.

Screen Shot 2017-03-12 at 11.37.30 AM

Strong evidence linked the Massachusetts case to recalled stone fruit, including food exposure interviews, receipt and shopper card data, and WGS results showing very high genetic relatedness between the patient’s isolate and isolates from nectarines.

  • Food and Drug Administration. Recall—firm press release: Wawona Packing Co. takes precautionary step of voluntarily recalling fresh, whole peaches, plums, nectarines, and pluots because of possible health risk. Available at http://www.fda.gov/Safety/Recalls/ucm405943.htm.
  • Food and Drug Administration. Recall—firm press release: Wawona Packing Co. expands its voluntary recall of fresh, whole peaches, plums, nectarines, and pluots because of possible health risk. Available at http://www.fda.gov/Safety/Recalls/ucm407600.htm.

ucm545298Illnesses reported in Connecticut, New Your and Vermont – and possibly other States – at least one and perhaps two deaths.  See, Vulto Creamery Cheese Listeria Lawsuit

Vulto Creamery, Walton, New York, is recalling all lots of Ouleout, Miranda, Heinennellie, and Willowemoc soft wash-rind raw milk cheeses  out of an abundance of caution due to testing result from the US Food & Drug Administration (FDA), which found Ouleout lot # 617 positive for Listeria monocytogenes and New York Department of Agriculture and Markets finding the possible contamination of Ouleout lot #623.

Product photos of all four cheese items being recalled along with a brief description are shown.  If you have any of this soft, wash-rind raw-milk cheese, please do not consume it.  The soft raw milk cheeses were distributed nationwide, with most being sold at retail locations in the Northeastern and Mid-Atlantic States, California, Chicago, Portland and Washington, DC.

Consumers that have any of these soft raw milk cheeses from Vulto Creamery should return the cheese to the purchase location for a refund.  Food and cheese wholesalers and retailers with any of the Vulto Creamery soft, wash-rind raw milk cheeses on hand should immediately remove these products from common storage coolers and quarantine these cheeses in a secured area of a cooler.  Any wholesaler or distributor that has any of the four cheeses should contact Vulto Creamery to receive instructions on what to do with the cheese.   The production of the product has been suspended while FDA and the company  continue to investigate the source of the problem.

UCM539413I must admit that I was a bit perplexed with the flurry of activity since the inaguaration, that there would be more recalls, but these are the first.

Barberi International Inc., based in Miami, Florida, is recalling its Sunmba Frozen Ajiaco (vegetable mix) product across Florida due to possible contamination with Listeria monocytogenesListeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

The Sunmba Frozen Ajiaco (vegetable mix) product being recalled was sold in 2 lb. plastic bags with the UPC number 85641400172 and with a “use by” date of Nov. 5, 2017, or earlier. This product was distributed in Florida and sold to the below stores between December 24, 2016 thru January 22, 2017. Out of an abundance of caution, Barberi International Inc. is recalling this product from these stores.

Listeria monocytogenes was discovered in the Sunmba Frozen Ajiaco after Florida Department of Agriculture and Consumer Services product testing.

tome-berger-des-sources-2-kilos Fromi USA. of New York, NY, is recalling its 7 cases of Soureliette cheese and 2 cases of Tomme Brebis Fedou because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled Tomme Brebis Fedou cheese and Soureliette were distributed to CA, NY and MA through retail stores.

The product Soureliette comes in a 3lb box marked with an expiration date of 02/22/2017; 01/25/2017 and 08/02/2017 stamped on the top.

The product Tomme Brebis Fedou comes in a 3lb box marked with an expiration date of 02/22/2017 stamped on the top.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine testing by the foreign supplier revealed the presence of Listeria monocytogenes in 3lb packages of Tomme Brebis Fedou cheese and Soureliette.

 

Sabra-Classic-HummusSabra Dipping Co., LLC is voluntarily recalling certain hummus products made prior to November 8, 2016 due to concerns over Listeria monocytogenes, which was identified at the manufacturing facility but not in tested finished product. The recall includes the products listed below; these were distributed to retail outlets, including food service accounts and supermarkets, in the U.S. and Canada.

Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea.  Listeria infection can cause miscarriages and stillbirths among pregnant women.  The company is issuing this recall out of an abundance of caution.

Consumers with any product with a “Best Before” date up through January 23, 2017 are urged to discard it. Consumers can find code and “Best Before” date on the lid of each package.

See complete list of recalled products.

And, it happened in 2015 too.

recalled-cheese-Oasis-BrandAccording to the US Attorney’s Office, a Miami-Dade County resident was sentenced to 15 months in prison, by U.S. District Judge Robert N. Scola, Jr., for distributing contaminated cheese.  Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, and Justin Green, Special Agent in Charge, U.S. Food and Drug Administration, Office of Criminal Investigations (FDA-OCI), Miami Field Office, made the announcement.

Christian Rivas, the owner of Oasis Brands, Inc. (“Oasis”), located in Miami, Florida, previously pled guilty to a two-count criminal Information.  Pursuant to Count 1, a felony, Rivas, with the intent to defraud and mislead, delivered cheese processed and packed at the Oasis facility into interstate commerce that was “adulterated . . . in that it contained lysteria monocytogenes (“listeria”) a deleterious substance, which may render the food injurious to health,” in violation of Title 21, United States Code, Section 331(a) and 333(a)(2).  Pursuant to Count 2, a misdemeanor, Rivas, as the responsible corporate official of Oasis, delivered cheese into interstate commerce, “which was prepared, packed and held [at the Oasis facility] under insanitary conditions whereby it may have been rendered injurious to health,” in violation of Title 21, United States Code, Section 331(a) and 333(a)(1).

recalled-Oasis-cheeseAccording to the court record, including the sentencing hearing and stipulated statement of facts in support of Rivas’ guilty plea, the Virginia Department of Agriculture and Consumer Services had alerted the FDA to the fact that cheese supplied by Oasis and located at a Virginia grocery store had been randomly sampled on July 26, 2014 and had tested positive for the presence of listeria.  A resulting FDA inspection of the Oasis processing facility revealed “numerous failures to comply with current Good Manufacturing Practice federal regulatory standards,” as well as several environmental swab samples taken from within the facility which tested positive for the presence of listeria.

At the close of the first inspection on August 22, 2014, Rivas agreed to do the following: (1) suspend manufacturing of new cheese products; (2) hire a consultant to inform the firm how to clean its facility; (3) stop distribution of finished food products in its inventory until a laboratory (retained by Oasis at its cost) could confirm that Oasis’ cheese products and its facility were negative for listeria; and (4) place all in-process product which was in the process of being manufactured or packaged and on the verge of distribution on hold until further discussions with FDA officials.

From October 7 through December 16, 2014, the FDA conducted a follow-up inspection at the Oasis facility and collected product samples of “Lacteos Santa Martha Cuajada en Hoja Fresh Curd,” then in storage at the facility, one of which later tested positive for listeria.

The court record indicates that subsequent to the first inspection and during the period September 24, 2014 through October 1, 2014, Rivas had, in violation of his agreement with the FDA, finished packaging multiple trays of cheese then held in-processing and had gone on to ship and distribute these items.  The cheese in question also consisted of numerous cases of individually packaged “Lacteos Santa Martha Cuajada en Hoja Fresh Curd.”  Rivas had initiated these shipments after he had learned from his testing laboratory, on September 24, 2014, that a sample of this same product had tested positive for the presence of listeria.

During the course of the sentencing hearing, the Court was informed that the Centers for Disease Control (CDC) had determined through DNA testing that an identified number of individuals were physically harmed as a consequence of having consumed contaminated cheese from Oasis during the summer and fall of 2014.

According to the CDC, the outbreak traced to the Oasis Brand cheese sickened people in Georgia, New York, Tennessee and Texas. Three of the illnesses were related to pregnancy, with one newborn diagnosed with Listeria infection.

Rivas joins other food industry executives sentenced to federal prison on criminal counts related to outbreaks. Those cases include:

  • Austin “Jack” DeCoster and his son Peter DeCoster sentenced in the Quality Egg case related to a 2010 Salmonella outbreak; and
  • Stewart Parnell and his brother Michael Parnell, along with Mary Wilkerson, sentenced in the Peanut Corporation of America case related to an E. coli outbreak.

eggo_leggo_white_shirt_popKellogg Company announced Monday it will recall approximately 10,000 cases of Eggo Nutri-Grain Whole Wheat Waffles after they were possibly contaminated with the bacteria listeria.

Kellogg announced on its website that no other Eggo products are impacted by the recall, which is being done voluntarily.

Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

No one has fallen sick yet due to the potentially-tainted waffles, Kellogg says, and added that they are taking the action as part of a “commitment to the health and safety of the people who eat (Kellogg) foods.”
The Eggo Waffles being recalled were distributed to customers and retailers in 25 states (CO, CT, DE, GA, IA, IL, IN, KS, MA, MD, ME, MI, MN, MO, ND, NE, NH, NJ, NY, OH, PA, VA, VT, WI, WY).

The affected product is:

Kellogg’s ® Eggo® Nutri-Grain® Whole Wheat Waffles
UPC Code: 38000 40370
The “Used by” date will read either November 21st and 22nd of 2017.
The date code can be found on the side of the package.

Kellogg said “a series of routine tests” uncovered the possible contamination risk.