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

Germany - Federal Report Indicates Campylobacter Rates Still High in Poultry Despite Regulations

In a report issued by the German BVL, the detection rates of Campylobacter remain high with nearly half of the bird carcasses positive with a quarter with counts above 1000 cfu/gr.  This indicates the difficulty in controlling a natural contaminate like Campylobacter in poultry.

German Federal Office of Consumer Protection and Food Safety (BVL)
https://www.bvl.bund.de/EN/Home/home_node.html
Translated via Google Translate
https://www.bvl.bund.de/SharedDocs/Pressemitteilungen/01_lebensmittel/2019/2019_11_19_PI_Zoonosen_Monitoring_2018.html
Still high Campylobacter rates in broilers
Process hygiene criterion shows not yet hoped for effect

NJ Firm Recalls Fruit Salad Product After Linked to Salmonella Outbreak in PA Healthcare Facilities

Tailor Cut Produce of New Jersey, is recalling its Fruit luau, cut honeydew, cut cantaloupe and cut pineapple products after they were linked to the Salmonella outbreak in Pennsylvania healthcare facilities.  In this outbreak, 31 people were infected across 4 healthcare facilities.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tailor-cut-produce-recalls-cut-fruit-mix-because-possible-health-risk
Tailor Cut Produce Recalls Cut Fruit Mix Because of Possible Health Risk
Summary
Company Announcement Date: December 07, 2019
FDA Publish Date:December 08, 2019
Product Type:Food & Beverages  Snack Food Item
Foodborne Illness Reason for Announcement:  Potential to be contaminated with Salmonella
Company Name:Tailor Cut Produce
Brand Name: Tailor Cut Produce
Product Description:  Fruit Luau

White Castle Recalls Retail Pack of Hamburger Sliders After Listeria Positive Test

White Castle is recalling their retail hamburger sandwich product / sliders after a third party laboratory tested and found Listeria on finished product.

This is a fully cooked product with heat and serve instructions.

According to the recall announcement, the company "is taking the following actions at the facility where the problem was identified:
•Intensive sanitation and cleaning with guidance from outside food safety experts.
•Aggressively elevating already strong food safety testing and manufacturing guidelines.
•Conducting comprehensive testing to confirm no presence of listeria in the facility. “This voluntary recall is precautionary and is the right thing to do,” said Richardson."

Note that the product is under FDA jurisdiction vs USDA.  This is a closed sandwich which falls under FDA jurisdiction.  (USDA regulations are limited to open faced sandwiches  - "Must contain at least 50 percent cooked meat. Sandwiches are amendable (USDA inspected) only if they are open faced sandwiches."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/white-castle-frozen-food-division-announces-voluntary-recall-limited-production-frozen-sandwiches
White Castle Frozen Food Division Announces Voluntary Recall of a Limited Production of Frozen Sandwiches Sold in Select Grocery Outlets Due to Possible Presence of Listeria Monocytogenes
Summary
Company Announcement Date: December 06, 2019
FDA Publish Date:December 06, 2019
Product Type:Food & Beverages Prepared Food
Foodborne Illness Reason for Announcement: Potential Listeria monocytogenes contamination
Company Name:White Castle Frozen Food Division
Brand Name: White Castle
Product Description: Frozen Cheeseburger and hamburger sliders

Salmonella Outbreak in PA Health Facilities Linked to NJ Fresh Fruit Facility

Investigators have found a potential source of the  Salmonella. outbreak in five PA healthcare facilities that has affected 31 people to date.  The outbreak was caused by Salmonella Javiana and has been linked to fruit mix with cantaloupe, honeydew, pineapple, and grapes from Tailor Cut Produce of North Brunswick, New Jersey.

While it is hard to know what failure may have caused the issue (if indeed this is the source), facilities such as this generally use surface washes with an antimicrobial to reduce potential contamination on the exterior of the produce.  So either the surface treatment(s) was not inadequate or there was a post-wash contamination issue.   Being a high risk populations (people in hospitals and elderly care facilities), a lower level of Salmonella is enough to cause issues.  For facilities knowingly supplying these types of facilities, extra emphasis must be placed on contamination control.

Sourcing is another key...working with growers who follow good agricultural practices, whether those are domestic or foreign growers.

FDA Outbreak Update
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-potentially-linked-tailor-cut-produce-fruit-mix-winter-2019
Outbreak Investigation of Salmonella Potentially Linked to Tailor Cut Produce Fruit Mix, Winter 2019
Food service companies and institutions in Pennsylvania, New York, and New Jersey should not serve cut fruit from Tailor Cut Produce

Case Counts

Total Illnesses: 31

States with Cases: PA 

December 6, 2019

FDA and the Pennsylvania Department of Health (DOH) are investigating an outbreak of illnesses caused by Salmonella Javiana in Pennsylvania. Epidemiologic and traceback evidence indicate that fruit mix with cantaloupe, honeydew, pineapple, and grapes from Tailor Cut Produce of North Brunswick, New Jersey, are a potential source of this outbreak.

This Week in Mislabeled Product for Week Ending December 7, 2019

Milk Found in Product - Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens in the 7.5-ounce packages of Nancy Adams, Dark Chocolate Graham Crackers which did not declare a milk ingredient on the label.

Sulfites and Cyclomate Found in Product - Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department’s Food Laboratory personnel revealed the presence of sulfites and cyclamates in these products which were not declared on the labels. Cyclamate is an unapproved ingredient.  What is a waxberry - LINK.

Soy Missing on Label - Blue Grass Quality Meats, an Erlanger, Ky. establishment, is recalling approximately 121,083 pounds of pork bacon and ready-to-eat turkey products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain soy, a known allergen, which is not declared on the product labels.

CBD Products Come Under Fire from Lawsuits After FDA Warning Letters Issued

As one could have guessed, it did not take long for lawsuits involving CBD products after FDA issued Warning Letters to a number of CBD-related companies.  The lawsuits take on a number of issues including the fact it is not allowed by federal law, that the levels are not controlled, and that THC can be present in the product.

.  "On November 27, plaintiff Adam DaSilva filed suit against Infinite Product Co alleging the company sells food, supplement and cosmetic products that are unapproved new drugs in violation of federal law. DaSilva said in the proposed class action suit that Infinite Product’s CBD products are misleadingly labeled and are illegal to sell. In the complaint, DaSilva pointed to the FDA’s recent warning letter to Infinite Products, detailing numerous violations regarding its products, including skin creams and gummies"

A California company that manufactured chocolate with CBD was "hit with a proposed class action in California federal court claiming the candies don’t contain the advertised amounts of CBD and THC."  There were also a few cases where truck drivers failed THC-in-blood test after using CBD product

National Law Review
https://www.natlawreview.com/article/proposed-class-action-alleges-company-s-cbd-products-violate-federal-law

Proposed Class Action Alleges Company’s CBD Products Violate Federal Law

PA Dept of Health Issues Advisory in SEPA Healthcare Facilities after 29 Cases of Salmonella

The Pennsylvania Dept of Health issued an advisory regarding a Salmonella outbreak in 4 healthcare facilities in southeastern PA.  "To date, we have identified 29 case-patients who spent time during their incubation periods in one of four healthcare facilities experiencing outbreaks, which include two hospitals and two long-term care facilities (LTCFs). Known onset dates range from November 19-November 30, 2019."

https://www.radnor.com/CivicAlerts.aspx
PENNSYLVANIA DEPARTMENT OF HEALTH 2019: Health Advisory Regarding Salmonella
Posted on: December 5, 2019