FDA Scales Back Foreign and Domestic Inspections Due to COVID-19

In light of the current COVID-19 pandemic, FDA announced that they will be scaling back domestic inspections.  They earlier announced that they would be postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-regulated-products-while-scaling-back-domestic
Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
For Immediate Release:
March 18, 2020

FDA Warning Letter - Company Fails to Control Labels Resulting In Allergen-related Recall

FDA issued a Warning Letter to Dianne's Fine Desserts after they recalled peanut butter brownies labeled in chocolate turtle brownie packaging because the product was 'misbranded' in that the finished product labels did not declare a major food allergen (peanuts)

According to the report, the firm recalled peanut butter brownies that were packaged in turtle brownie labeling, indicating that the problem “was caused by a temporary breakdown in your production and packaging processes.” In an email to FDA, the company  stated that there had been “opportunity during product changeover to introduce pre-printed packaging material to the line before changeover is completed.” The email also stated that the company "implemented corrective actions to the line clearance procedures and provided a summary of the changes, including controlling packaging on and in the area of production lines, checking and documenting that the correct packaging is on the line, utilizing photo standards of labeling, and training employees."

While FDA has not verified the corrective action, they issued the Warning Letter stating, "your food allergen controls are not adequate at the packaging step to ensure that your finished food is not misbranded under section 403(w) of the Act as evidenced by your firm’s packaging of peanut butter brownies into containers labeled for turtle brownies. This incorrect labeling caused your product to contain an undeclared major food allergen."


FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/diannes-fine-desserts-600026-03022020
Dianne's Fine Desserts
MARCS-CMS 600026 — March 02, 2020

FDA Warning Letter - Another Importer with No FSVP

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

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:

• 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

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)

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

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

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.

* ”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

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