FDA issued a Warning Letter to an importer for not having a FSVP in place for 1)Fried onions and 2)Basmati rice. FDA had never received a response to how the firm was going to rectify the situation.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunrise-distributors-inc-599020-02112020
Sunrise Distributors Inc
MARCS-CMS 599020 — February 11, 2020
Wednesday, March 18, 2020
FDA Warning Letter - A RTE Bakery in Puerto Rico
FDA issued a Warning Letter to a ready-to-Eat (RTE) bakery products manufacturing facility located in Toa Baja, Puerto Rico.
The facility did not conduct a hazard analysis for any products to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured or processed. And with that, they did not have a implemented a food safety plan or any preventive controls.
There were a host of GMP observations including:
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-ann-cake-inc-590155-10292019
Sweet Ann Cake, Inc.
MARCS-CMS 590155 — October 29, 2019
The facility did not conduct a hazard analysis for any products to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured or processed. And with that, they did not have a implemented a food safety plan or any preventive controls.
There were a host of GMP observations including:
- Pest issues
- Did not have good allergen control for equipment and utensils during use, with cleaning and in storage.
- Handwashing issues
- Plant cleanliness
- Water-related issues
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-ann-cake-inc-590155-10292019
Sweet Ann Cake, Inc.
MARCS-CMS 590155 — October 29, 2019
Monday, March 16, 2020
Cooked Shrimp Used in Sushi Operations Recalled for Vibrio parahaemolyticus
AFC Distribution Corp. (“AFC”) of Rancho Dominguez, California is voluntary recalling Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02, utilized in various prepared menu offerings with sell-by dates ranging from 02/19/2020 to 03/13/2020, because this ingredient may have a potential to be contaminated with Vibrio parahaemolyticus.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cooked-butterfly-tail-whiteleg-shrimp-sushi-ebi-lot-20191002
Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02
Summary
Company Announcement Date: March 13, 2020
FDA Publish Date: March 14, 2020
Product Type: Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name: AFC Distribution Corp.
Brand Name: AFC Distribution Corp.
Product Description: Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi)
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cooked-butterfly-tail-whiteleg-shrimp-sushi-ebi-lot-20191002
Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02
Summary
Company Announcement Date: March 13, 2020
FDA Publish Date: March 14, 2020
Product Type: Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name: AFC Distribution Corp.
Brand Name: AFC Distribution Corp.
Product Description: Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi)
Idaho Company Recalls Frozen Blackberries After FDA Test Finds Norovirus
WinCo Foods, LLC. of Boise, ID is recalling frozen Blackberries in a 16 oz. bag and frozen Berry Medley in 16 oz. and 32 oz. bags, manufactured by Rader Farms of Lynden, WA, because both products have the potential to be contaminated with Norovirus. No customer illnesses have been reported to date. WinCo Foods was informed by the FDA that a sample of the product was tested by the FDA and found to be contaminated with Norovirus
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/winco-foods-llc-recalls-frozen-blackberries-and-frozen-berry-medley-because-possible-health-risk
Winco Foods, Llc. Recalls Frozen Blackberries and Frozen Berry Medley Because of Possible Health Risk
Summary
Company Announcement Date: March 13, 2020
FDA Publish Date: March 13, 2020
Product Type: Food & Beverages
Reason for Announcement: Norovirus
Company Name: WinCo Foods, LLC
Brand Name: WinCo
Product Description: Frozen Blackberries and Frozen Berry Medley
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/winco-foods-llc-recalls-frozen-blackberries-and-frozen-berry-medley-because-possible-health-risk
Winco Foods, Llc. Recalls Frozen Blackberries and Frozen Berry Medley Because of Possible Health Risk
Summary
Company Announcement Date: March 13, 2020
FDA Publish Date: March 13, 2020
Product Type: Food & Beverages
Reason for Announcement: Norovirus
Company Name: WinCo Foods, LLC
Brand Name: WinCo
Product Description: Frozen Blackberries and Frozen Berry Medley
Friday, March 13, 2020
Supporting The Food Service Industry in Coronavirus Times - Order Out
Our new Coronavirus reality has been a boon to the toilet paper industry, but there will be many sectors that will be adversely affected, including the restaurant industry. In an attempt to minimize risk through avoiding large crowds and practicing social distancing, many will forgo eating out, especially buffets. But we can continue to support our restaurant scene by ordering out. This will minimize our social contact will providing our favorite eating spots with needed business. Restaurants would be wise to market those services and establish procedures to quickly and safety provide food to customers.
USA Todayhttps://www.usatoday.com/story/money/2020/03/11/coronavirus-restaurants-dining-in-food-safety-preparations/5025087002/
MONEY
Dine out or eat in during the coronavirus crisis? Here's what public health and food safety experts say
Jessica Guynn
Kelly Tyko
USA TODAY
Mar11, 2020
USA Todayhttps://www.usatoday.com/story/money/2020/03/11/coronavirus-restaurants-dining-in-food-safety-preparations/5025087002/
MONEY
Dine out or eat in during the coronavirus crisis? Here's what public health and food safety experts say
Jessica Guynn
Kelly Tyko
USA TODAY
Mar11, 2020
Coronavirus Versus the Flu....Not the Same
You have probably heard that Coronavirus is just like the flu and that the flu kills more people and many are just overreacting....so what are you missing?
The mortality rate is much higher with Coronavirus compared to the flu. For Corona virus, WHO estimates this number around 2 to 3 percent, although Dr. Fauci of NIH estimates it closer to 1%. For the seasonal flu, it is approximately 0.1%.* And while the elderly are more prone to illness for both, Coronavirus will adversely impact the more healthy among that group.
The mortality rate is much higher with Coronavirus compared to the flu. For Corona virus, WHO estimates this number around 2 to 3 percent, although Dr. Fauci of NIH estimates it closer to 1%. For the seasonal flu, it is approximately 0.1%.* And while the elderly are more prone to illness for both, Coronavirus will adversely impact the more healthy among that group.
* ”On the actual case fatality rate: "There's the number of cases that have come to the attention of healthcare providers. As of [Friday] morning, that’s like 98,000. Then on the other side, you have the number of documented deaths. That’s now like 3,700, 3,800. When you do that pure simple math, the deaths are the numerator, the cases are the denominator, that’s where you get the report from WHO that it’s somewhere between a 2% and 3% case fatality rate. However, when people do modeling … you have various assumptions that there are this many asymptomatic cases that never get counted. When you do that, you get a range of case fatality rates that always less than the actual numerical one because it always factors in relative proportions of asymptomatic ones that we don’t count." (Ref)
Symptoms - symptoms for serious cases have required hospitalization with breathing support such as ventilation. As seen in Italy where there has been a spike of illness, this has resulted in a overburdened medical support system.
Infectiousness - Coronavirus has been determined to be about twice as infectious. Europe is midst of an increase number of cases.
Treatment - Coronavirus - no current vaccine and antivirals have had minimal impact.
And overall, there are just more unknowns about the Coronavirus, such as seasonal impacts, ability to reinfect, etc.
https://www.sciencealert.com/the-new-coronavirus-isn-t-like-the-flu-but-they-have-one-big-thing-in-common
No, Coronavirus Isn't 'Just Like The Flu'. Here Are The Very Important Differences
AFP 11 MARCH 2020
Infectiousness - Coronavirus has been determined to be about twice as infectious. Europe is midst of an increase number of cases.
Treatment - Coronavirus - no current vaccine and antivirals have had minimal impact.
And overall, there are just more unknowns about the Coronavirus, such as seasonal impacts, ability to reinfect, etc.
https://www.sciencealert.com/the-new-coronavirus-isn-t-like-the-flu-but-they-have-one-big-thing-in-common
No, Coronavirus Isn't 'Just Like The Flu'. Here Are The Very Important Differences
AFP 11 MARCH 2020
Imported Korean Mushrooms Linked to Listeria Outbreak With 36 Affected Including 6 Deaths
Mushrooms imported from Korea have been linked to a serious Listeria outbreak where 36 cases have been reported with 4 deaths. Six of the cases were pregnant women where two of the deaths were fetal.
Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) due to the potential to be contaminated with Listeria monocytogenes. Consumers are warned not to even if it does not look or smell spoiled.
Sun Hong Foods became aware of this issue after notification by FDA that samples of the product tested by the State of Michigan were found to be positive for Listeria monocytogenes.
https://www.cdc.gov/listeria/outbreaks/enoki-mushrooms-03-20/index.html
Outbreak of Listeria Infections Linked to Enoki Mushrooms
Posted March 10, 2020 at 4:30 PM ET
At A Glance
Reported Cases: 36
States: 17
Hospitalizations: 30
Deaths: 4
Recall: Yes
Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) due to the potential to be contaminated with Listeria monocytogenes. Consumers are warned not to even if it does not look or smell spoiled.
Sun Hong Foods became aware of this issue after notification by FDA that samples of the product tested by the State of Michigan were found to be positive for Listeria monocytogenes.
https://www.cdc.gov/listeria/outbreaks/enoki-mushrooms-03-20/index.html
Outbreak of Listeria Infections Linked to Enoki Mushrooms
Posted March 10, 2020 at 4:30 PM ET
At A Glance
Reported Cases: 36
States: 17
Hospitalizations: 30
Deaths: 4
Recall: Yes
This Week in Mislabeled Products for Two Weeks, Ending March 14, 2020
Incorrect Back Label - Pero Family Farms Food Company, LLC has initiated a voluntary product recall of its 11oz “Zucchini Spiral Pesto Side Dish Kit” with run number code 1196272F; Use By date of 03/20/2020 due to a product mislabeling which did not declare the allergens of egg and milk.
Someone Added Brazil Nuts Where They Shouldn't Have - Meijer is initiating a voluntary recall of 13,284 packages of mixed nuts due to the potential risk of an undeclared tree-nut allergen (Brazil nuts) sold at all Meijer stores, and is being issued to its customers in cooperation with the U.S. Food & Drug Administration. The recall was initiated after it was discovered the product contained Brazil nuts, which is not part of the product formulation or declared on package labeling. Subsequent investigation revealed an incorrect formulation was used to manufacture this product and should not have included the Brazil nuts.
Wrong Master Pack Label Used - Dole Fresh Vegetables, Inc. is initiating a limited voluntary recall of H-E-B-branded Tuscan Herb Chopped Salad due to possible undeclared allergens (peanut, wheat, soy and tree nuts) in H-E-B-branded Tuscan Herb Salad Kit, which was manufactured by Dole for H-E-B. The incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad.
Herring In Cream Sauce Mislabeled as Herring In Wine Sauce - Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling up to 8,376 individual plastic jars of 32 ounce Vita Wild Herring in Wine Sauce that are potentially mislabeled because they may contain sour cream and, therefore, may contain undeclared milk. Mislabeled products that are subject to recall will be obvious to consumers because the recalled product’s white sour cream sauce can be seen through the clear plastic jar even though the label may state “Vita Wild Herring in Wine Sauce”.
Queso Product Labeled as Salsa Product Misses Milk and Soy - Stonewall Kitchen of York, Maine is voluntarily recalling 4,812 jars of its Ghost Pepper Queso with an Enjoy By date of 23MAY2021, as a small number of those were mislabeled as Ghost Pepper Salsa. Ghost Pepper Queso includes two allergens, milk and soy, that are not included in Ghost Pepper Salsa, and therefore don’t appear on the ingredient statement of the mislabeled jars. While Stonewall Kitchen believes that only a small number of jars were mislabeled out of the 4,812 which were manufactured that day, the company is recalling all of them out of an abundance of caution. Of note, the mislabeled jars should be very easy to spot: Ghost Pepper Queso product is a bright yellow-orange color, while Ghost Pepper Salsa is dark red.
Print-and-Apply Label Does Not List Milk Ingredient - Whole Foods Market is voluntarily recalling select Green Chile Chicken Tamales from stores across 24 states because they contain undeclared milk. A print-and-apply label did not have milk ingredient listed in the ingredient statement.
New Label Design Uses Incorrect Termonology Not Stating Milk - New Capstone, Inc. of Mooresville, NC is recalling their 22oz ReStructure Vanilla Protein Powder pouches, Lot 19211 Exp. 06/21 and their 27 gram individual serving pouch, Lot 19211 Exp. 06/21, because they may contain undeclared milk. The recall was initiated after it was discovered that the new product pouch design omitted the clear statement that the product contained milk but rather just stated the product contained lactose. Subsequent to this discovery New Capstone, Inc. added a milk allergen warning sticker to all remaining packages in Lot 19211.
Someone Added Brazil Nuts Where They Shouldn't Have - Meijer is initiating a voluntary recall of 13,284 packages of mixed nuts due to the potential risk of an undeclared tree-nut allergen (Brazil nuts) sold at all Meijer stores, and is being issued to its customers in cooperation with the U.S. Food & Drug Administration. The recall was initiated after it was discovered the product contained Brazil nuts, which is not part of the product formulation or declared on package labeling. Subsequent investigation revealed an incorrect formulation was used to manufacture this product and should not have included the Brazil nuts.
Wrong Master Pack Label Used - Dole Fresh Vegetables, Inc. is initiating a limited voluntary recall of H-E-B-branded Tuscan Herb Chopped Salad due to possible undeclared allergens (peanut, wheat, soy and tree nuts) in H-E-B-branded Tuscan Herb Salad Kit, which was manufactured by Dole for H-E-B. The incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad.
Herring In Cream Sauce Mislabeled as Herring In Wine Sauce - Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling up to 8,376 individual plastic jars of 32 ounce Vita Wild Herring in Wine Sauce that are potentially mislabeled because they may contain sour cream and, therefore, may contain undeclared milk. Mislabeled products that are subject to recall will be obvious to consumers because the recalled product’s white sour cream sauce can be seen through the clear plastic jar even though the label may state “Vita Wild Herring in Wine Sauce”.
Queso Product Labeled as Salsa Product Misses Milk and Soy - Stonewall Kitchen of York, Maine is voluntarily recalling 4,812 jars of its Ghost Pepper Queso with an Enjoy By date of 23MAY2021, as a small number of those were mislabeled as Ghost Pepper Salsa. Ghost Pepper Queso includes two allergens, milk and soy, that are not included in Ghost Pepper Salsa, and therefore don’t appear on the ingredient statement of the mislabeled jars. While Stonewall Kitchen believes that only a small number of jars were mislabeled out of the 4,812 which were manufactured that day, the company is recalling all of them out of an abundance of caution. Of note, the mislabeled jars should be very easy to spot: Ghost Pepper Queso product is a bright yellow-orange color, while Ghost Pepper Salsa is dark red.
Print-and-Apply Label Does Not List Milk Ingredient - Whole Foods Market is voluntarily recalling select Green Chile Chicken Tamales from stores across 24 states because they contain undeclared milk. A print-and-apply label did not have milk ingredient listed in the ingredient statement.
New Label Design Uses Incorrect Termonology Not Stating Milk - New Capstone, Inc. of Mooresville, NC is recalling their 22oz ReStructure Vanilla Protein Powder pouches, Lot 19211 Exp. 06/21 and their 27 gram individual serving pouch, Lot 19211 Exp. 06/21, because they may contain undeclared milk. The recall was initiated after it was discovered that the new product pouch design omitted the clear statement that the product contained milk but rather just stated the product contained lactose. Subsequent to this discovery New Capstone, Inc. added a milk allergen warning sticker to all remaining packages in Lot 19211.
Tuesday, March 3, 2020
Review - The Risk of Pathogen Spillover from Wild Birds
Wild birds can carry pathogens, such as Campylobacter and Salmonella, that can become contaminants for food. Most of our concern is in the fields with crops that will receive minimal processing, but also in instances where birds gain access into our processing facilities. A recent review of the research shows that we probably overemphasize the risk, but more research is needed in understanding transmission from birds to our food systems.
Biological Reviews
https://onlinelibrary.wiley.com/doi/full/10.1111/brv.12581
Are we overestimating risk of enteric pathogen spillover from wild birds to humans?
Olivia M. Smith William E. Snyder Jeb P. Owen
First published: 31 January 2020 https://doi.org/10.1111/brv.12581
"We conclude that current data do not provide sufficient information to determine the likelihood of enteric pathogen spillover from wild birds to humans and thus preclude management solutions. The primary focus in the literature on pathogen prevalence likely overestimates the probability of enteric pathogen spillover from wild birds to humans because a pathogen must survive long enough at an infectious dose and be a strain that is able to colonize humans to cause infection."From their paper:
"Campylobacter spp. 14.8%(64/431)of North American breeding birds had Campylobacter spp. prevalence data (1+ observations) meeting our inclusion criteria 1–9 (Data S2). The species with the most observations meeting our inclusion criteria 1–9 were rock pigeon [N= 3659from 15 studies, range 6–1800 individuals tested, 0.1–70% reported prevalence, estimated prevalence 16± 5.3%(SE)],European starling[N= 2094 from 12 studies, range 1–957 individuals tested, 0–75% reported prevalence, estimated prevalence 28 ± 6.0% (SE)],...."
"Salmonella spp. were the most studied bacteria with 33% (141/431) of North American breeding birds having prevalence data (1+ observations) meeting our inclusion criteria 1–9. The species with the most observations of data meeting inclusion criteria 1–9 were herring gull [N = 12470 from 10 studies, range 1–5324 individuals tested, 0–22% prevalence,estimated prevalence 8.2± 2.2%(SE)],house sparrow [N = 5581 from 19 studies, range 2–1124 individuals tested, 0–21% prevalence, estimated prevalence 2.5 ± 0.7% (SE)], rock pigeon [N = 5458 from 30 studies, range 4–1800 individuals tested, 0–100% prevalence, estimated prevalence 4.0 ± 0.9% (SE)..."So birds can carry pathogens, and we need to keep them out of food processing facilities, but with field crops, further work is needed before we go to the levels of habitat destruction.
Biological Reviews
https://onlinelibrary.wiley.com/doi/full/10.1111/brv.12581
Are we overestimating risk of enteric pathogen spillover from wild birds to humans?
Olivia M. Smith William E. Snyder Jeb P. Owen
First published: 31 January 2020 https://doi.org/10.1111/brv.12581
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