FDA Warning Letter to RTE Cheese Processor

FDA issued a Warning Letter to a cheese facility in Miami.  Issues include no Preventive Control Plan and really poor GMPs (dripping condensate, leaking pipes, and inadequate sanitation).  And they are producing RTE cheese product of some sort.

The thing that gets you is the company name....US Dairy Unlimited.   You are thinking with a name like that, that is a serious operation.  Could have called it Ury's Cheese, but who would buy that.  But US Dairy Unlimited....there are no limits to what they can do, or so one would think.

But looking at the facility (based on address from notice on Google Map Street view), it looks like nothing like Dairy Unlimited.  Not to say they can't make good products, but if this is your supplier, you may want to investigate a little closer.  For example, your purchasing person informs you that they have contracted a new co-packer....US Dairy Unlimited.  What supplier approval process granted this?

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-dairy-unlimited-llc-590413-11192019
WARNING LETTER
U.S. Dairy Unlimited, LLC
MARCS-CMS 590413 — November 19, 2019

Tracking the E. coli Outbreaks - 3 Current Outbreaks

There are three current E. coli outbreaks that are being tracked by governmental agencies.  They appear to be unrelated. All are E. coli O157:H7, but they have been identified as different strains due to genetic differences. 
(Perhaps it is time to name these outbreaks like the Weather Channel has done with hurricanes and now does with storms.)

1. Salinas Romaine Lettuce

• 102 cases with 58 hospitalizations in 23 states
• Last case - November 18
• Source Romaine lettuce from Salinas CA

2. Salad kits from Fresh Express

• 8 cases with 3 hospitalizations in 3 states
• Last case - November 15
• Source Salad item, possibly Romaine lettuce

3. Washington Evergreen Restaurant

• 13 cases with 3 hospitalizations in one state (WA), Multiple outlets of one restaurant chain
• Last onset case - November 15
• Source not yet known

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-e-coli-o157h7-outbreak-linked-romaine-salinas-california-november-2019
Investigation of E. coli O157:H7 Outbreak Linked to Romaine from Salinas, California, November 2019
FDA continues to warn against eating romaine from Salinas; farm investigations continue
Updated December 12, 2019
Case Counts

• Total Illnesses: 102
• Hospitalizations: 58
• Deaths: 0
• Last illness onset: November 18, 2019
• States with Cases: AZ (3), CA (4), CO (6), FL (1), IA (1), ID (3), IL (1), MD (4), MI (1), MN (3), MT (1), NE (1), NJ (7), NC (1), NM (2), OH (12), OR (1), PA (8), SD (1), TX (4), VA (4), WA (2), WI (31)

This Week in Mislabeled Product for Week Ending December 14, 2019

Wrong Product Put in Package - Tropical Nut and Fruit Co. is voluntarily recalling their 25lb box of Truly Good Foods South of the Border nut mix because it contains undeclared soy and tree nut (almonds).  The voluntary recall was initiated after it was discovered that the wrong product was packaged inside the South of the Border box, therefore containing different allergens from what is stated on the label.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tropical-nut-and-fruit-co-issues-allergy-alert-undeclared-soy-and-tree-nut-almonds-their-truly-good
Tropical Nut and Fruit Co. Issues Allergy Alert of Undeclared Soy and Tree Nut (Almonds) on Their Truly Good Foods South of the Border Mix
Summary
Company Announcement Date: December 06, 2019 

FDA Publish Date: December 06, 2019

Product Type:Food & Beverages  Snack Food Item  Allergens 

Reason for Announcement:  Undeclared almond and soy
Company Name:Tropical Nut and Fruit Co. 

Brand Name:  Truly Good Foods
Product Description:  South of the Border nut mix

Smoked Salmon Recalled for Potential Listeria Contamination After FDA Testing

A Wallkill, NY establishment is recalling Cold Smoked Salmon after routine FDA environmental sampling and analysis determined that the product has the potential to be contaminated with Listeria monocytogenes


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/catsmo-llc-recalls-smoked-salmon-because-possible-health-risk
CATSMO LLC. Recalls Smoked Salmon Because of Possible Health Risk
Summary
Company Announcement Date: December 10, 2019
FDA Publish Date: December 10, 2019
Product Type: Food & Beverages  Fish  Foodborne Illness
Reason for Announcement: Listeria monocytogenes
Company Name: CATSMO LLC
Brand Name: CATSMO LLC
Product Description: Cold Smoked Salmon (whole fillets and specialty cuts)

NC - Police Find $3 Million in Barrels of Pork Shoulders

Police in NC discovered $3 million in cash hidden in a barrels of raw pork shoulders during a routine traffic stop of a tractor trailer.  The truck was believe to be headed to the US Mexican border and the cash was part of a drug money collection.


NY Daily News
https://www.nydailynews.com/news/crime/ny-three-million-in-cash-found-in-barrels-of-pork-in-north-carolina-20191211-at43radszfbpbgea2hwtkfcuzy-story.html
$3M in cash found in barrels of raw pork shoulder during traffic stop
Nelson Oliveira
By NELSON OLIVEIRA
NEW YORK DAILY NEWS |
DEC 11, 2019 | 10:24 AM

Talk about a piggy bank.

Why Does Bird Flu Not Cause a Major Outbreak in Humans?

Have you ever wondered why bird flu, although really bad for birds, is not as much an issue in humans?  Recent research provides us evidence of what is going on.  We'll attempt to summarize.

First, flu viruses are designated by two surface proteins H and N.
H - hemagglutinin, which enables the virus to infect human and animal cells where it can multiply,
N - neuraminidase, which helps the virus’s offspring to extract themselves from the infected cell.

So the virus enters the host cell, has the host replicate virus RNA which is used to make new viruses, and the high number of newly minted viruses explode out of the cell.  A person becomes sick as they fight off the viruses.  Worst case is when a person encounters new variants of  virus, that have different proteins including H and N, as would be the case with people getting a bird flu variant.  In this case, it takes the body longer to react to novel proteins of the variant, and the body has less defense system in place to fight the new virus.  The body reacts violently to counter the new virus, and it is this, the body's own defense system, that can be damaging (high fever, excessive phlegm, etc).

What this study found was that although the bird flu virus can infect a person, it does not replicate (make new virs) easily and thus does not spread easily.  The reason - the bird virus when in the human, does not produce a sufficient quantity of a protein, designated M1, responsible for getting the RNA out of the nucleus to begin making the new viruses in the cytoplasm of the host cell.   In humans, the bird viral RNA is spliced differently, making a protein called M2.

“Alternative splicing regulates which proteins are ultimately made from a single gene, because many genes code for more than one protein. When human cells are attacked by bird flu, this element ensures that more M2 rather than M1 protein is produced.”

May there be other factros? Sure.

 “How pathogenic an avian flu virus is and whether or not it has pandemic potential depends, of course, on many factors,” says Selbach. “A study on cell cultures cannot cover all these factors. Nevertheless, it might be useful in future to include an analysis of this RNA segment in the risk assessment of avian influenza viruses.”

https://www.mdc-berlin.de/news/press/what-blocks-bird-flu-human-cells
What blocks bird flu in human cells? 

Salad Kits Linked to E. coli Outbreak Affecting Eight, Not Same Strain as from Salinas Romaine Outbreak

CDC and other agencies are investigating a multistate outbreak of Shiga toxin-producing E. coli O157:H7 infections.  There have been 8 cases with 3 hospitalizations.  The cases of illness started on dates ranging from November 5, 2019, to November 15, 2019

Information collected to date indicates that Fresh Express Sunflower Crisp chopped salad kits are a likely source of this outbreak.  Of seven ill people with information available, all seven (100%) reported eating any leafy green in the week before their illness started. Six ill people reported eating or maybe eating a Fresh Express Sunflower Crisp chopped salad kit.  It is not yet known if this outbreak is related to a current outbreak linked to romaine lettuce from the Salinas, California, growing region, but the outbreak is caused by a different strain of E. coli O157:H7 than the current outbreak linked to romaine lettuce from the Salinas, California, growing region.

CDC Food Safety Alert
https://www.cdc.gov/ecoli/2019/o157h7-12-19/index.html
Outbreak of E. coli Infections Linked to Fresh Express Sunflower Crisp Chopped Salad Kits
Posted on December 9, 2019 at 6:45 PM ET

CDC, public health and regulatory officials in several states and Canada, and the U.S. Food and Drug Administration (FDA) are investigating a multistate outbreak of E. coli O157:H7 infections linked to Fresh Express Sunflower Crisp chopped salad kit.

At A Glance
Reported Cases: 8
States: 3
Hospitalizations: 3
Deaths: 0
Recall: No

FDA Warning Letter - Ice Cream Facility in MA

FDA sent a Warning Letter to an ice cream facility in MA.  Lots of good things to learn from this inspection.

One of the major issues was that the facility had a Listeria control issue.

One of the first citings was that the establishment said that it did not require a sanitation control for Listeria in the post process environment where the product is exposed.  The facility said that because it had SSOPs, GMPs, and environmental monitoring, these were reasons why it does not have to considered a preventive control.  Doesn't work that way.

our “FSMA/FOOD SAFETY PLAN” issued on June 10, 2019, lists pre-requisite programs (PP) and Sanitation Standard Operating Procedures (SSOP), “PP1- Environmental Monitoring,” “PP3-current Good Manufacturing Practices,” “SSOP1- Cleanliness of Food Contact Surfaces,” and “PP7-SSOPs,” at processing steps where food is exposed to the environment, as reasons that a hazard (e.g., L. monocytogenes) does not require a preventive control. However, for RTE foods exposed to the environment, SSOPs are sanitation controls that are verified by environmental monitoring. These measures should not be considered when determining whether sanitation preventive controls are needed. Environmental monitoring (e.g., Dean Foods’s corporate environmental monitoring program “PP1- Environmental Monitoring Preventive Control” and/or your facility specific “Pathogen Environmental Monitoring Program”) is needed to verify that environmental pathogens are being controlled by the sanitation control measures. 

 Listeria was found in the environment during the FDA inspection, the same strain in some cases that was found during an inspection in 2017.  The firm's own swabbing had found a high level of Listeria.

"from January 2019 through July 2019, 13.4% of all swabs taken were positive for Listeria spp.; from January 2018 through December 2018, 20.9% of all swabs taken were positive for Listeria spp.; and from January 2017 through July 2017, 16.4% of all swabs taken were positive for Listeria spp."

GMP issues (continues)

Frozen Burrito Products Recalled after 3 Consumer Complaints for White Plastic in Product

Ruiz Food Products Inc., a Florence, S.C. establishment, is recalling approximately 55,013 pounds of frozen, not ready-to-eat (NRTE) breakfast burrito products containing eggs, sausage, and cheese that may be contaminated with extraneous materials, specifically pieces of plastic.  The problem was discovered when the firm notified FSIS of three consumer complaints involving pieces of white, semi-rigid plastic found in the product.  There have been no confirmed reports of injuries due to consumption of these products.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-119-2019-release
Ruiz Food Products, Inc. Recalls Frozen Sausage Breakfast Burrito Products due to Possible Foreign Matter Contamination
Class I Recall
119-2019
Health Risk:High
Dec 10, 2019