Wednesday, December 7, 2022

Ham and Cheese Loaf Products Recalled After Being Sliced on Equipment Exposed to Under-processed Product

Kraft Heinz Foods Company, a Kirksville, Mo. establishment, is recalling approximately 2,400 pounds of ready-to-eat ham and cheese loaf products due to possible cross-contamination with under-processed products.  The problem was discovered when the establishment notified FSIS that the product was sliced on the same equipment as product that had been under processed, and the equipment was not cleaned between runs of the under-processed and fully cooked product. This has led to concerns of possible cross-contamination of the fully cooked ham and cheese loaf product.

This scenario is easy to imagine.  Product is produced that is under-processed and put on hold.  But the post-processing equipment, now exposed to under-processed meat potentially containing pathogens like Salmonella or Listeria, is not completely cleaned prior to running good product.

When under-processed product touches the equipment on the post-process side of the operation (what is considered the RTE side or clean side of the operation), then all that equipment must receive a complete sanitation.

https://www.fsis.usda.gov/recalls-alerts/kraft-heinz-foods-company-recalls-ready-eat-ham-and-cheese-loaf-products-due
Kraft Heinz Foods Company Recalls Ready-To-Eat Ham and Cheese Loaf Products Due to Possible Cross-Contamination From Under-Processed Products
KRAFT HEINZ FOODS COMPANY

FSIS Announcement

WASHINGTON, Dec. 5, 2022 – Kraft Heinz Foods Company, a Kirksville, Mo. establishment, is recalling approximately 2,400 pounds of ready-to-eat ham and cheese loaf products due to possible cross-contamination with under-processed products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Chilean Frozen Raspberries Recalled After FDA Detects Hepatitis A

Exportadora Copramar is recalling 1260 cases of James Farm frozen raspberries due to the potential of the product being contaminated with Hepatitis A.  U.S. Food and Drug Administration (FDA) testing indicated the presence of Hepatitis A in James Farm branded frozen raspberries identified by UPC Code: 76069501010 and Lot Code - 22-165.  The product is exclusively sold through Restaurant Depot/Jetro locations in New York, New Jersey, Connecticut, Massachusetts, Rhode Island, Pennsylvania, Maryland, Virginia and Delaware.  Product is from Chile.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exportadora-copramar-recalls-james-farms-frozen-raspberries-due-possible-health-risk
Exportadora Copramar Recalls James Farms Frozen Raspberries Due to Possible Health Risk
Summary
Company Announcement Date:  December 03, 2022
FDA Publish Date: December 03, 2022
Product Type: Food & Beverages Fruit/Fruit Product
Reason for Announcement:  Hepatitis A
Company Name:  Exportadora Compramar
Brand Name:  James Farms
Product Description:  Frozen Raspberries

Low Fat Pet Food Recalled After Consumers Notice Product with Gravy

"NestlĂ© Purina PetCare Company is voluntarily recalling a limited amount of Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food in 13.4 oz cans due to a labeling error. For a brief period on September 15, 2022, cans of a different complete and balanced adult dog food, Purina ONE True Instinct Tender Cuts In Gravy With Real Turkey & Venison wet dog food, were labeled as PPVD EN Low Fat in one of our factories. The mislabeled diet is safe to feed, but it is not the intended formula for dogs requiring a prescription PPVD EN Low Fat diet, who may have sensitivities to traditional diets or difficulty digesting fat."  The company became "aware of the issue after being contacted by several pet owners who observed the texture of food in their PPVD EN Low Fat cans was not the same as previous meals. The mislabeled product contains chunks in gravy, while the correct product looks more like a pate consistency."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-purina-petcare-company-voluntarily-recalls-limited-amount-purina-pro-plan-veterinary-diets-en
Nestlé Purina PetCare Company Voluntarily Recalls a Limited Amount of Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat Wet Dog Food Due to Labeling Error
Summary
Company Announcement Date: November 30, 2022
FDA Publish Date:  December 02, 2022
Product Type:  Animal & Veterinary  Pet Food 
Reason for Announcement:  Mislabeling
Company Name:  Nestle Purina PetCare Company
Brand Name:  Labeling error
Product Description:  Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food

Tuesday, November 29, 2022

FDA Warning Letter to CA Bakery for Having No Food Safety Plan and Having GMP Issues

FDA issued a Warning Letter to The Bonami Baking Company, Inc. of  Pittsburg, CA, a manufacturer of ready-to-eat (RTE) bakery products.  Basically, the company did not have a Food Safety Plan, so there was no evaluaiton for allergens or pathogens or mycotoxins.   On top of that, there was numerous GMP issues with a high number of insect-related sightings.  Finally, there were some misbranding issues.

Now, if one looks at the compay website, it looks like a legitimate operation. 
The Bonami Baking Company, Inc.
MARCS-CMS 633746 — SEPTEMBER 07, 2022

FDA Issues Warning Letter to MA Fudge Processing Company

FDA issued a Warning Letter to Winfrey's Olde English Fudge, Inc. of  Rowley, MA, a producer of ready-to-eat (RTE) enrobed chocolates and fudge, including Milk Chocolate Pretzels and Milk Chocolate Peanut Butter Mini Eggs.

  1. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control - 
  • "Did not identify and evaluate the hazard of allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. The company manufactures multiple products with different allergen profiles on the same day and on shared equipment, which can result in allergen cross-contact without appropriate controls"

FDA Issues Updated Version of Allergen Guidance for Comment

FDA issued updated Q&A guidance documents (5th edition) on allergen labeling.   The original document (4th edition) was spit into two sets....one being the updated set of Q&A which is labeled as 5th ed. Draft, and the other being those original Q&A are in the document labeled 5th ed. Final.  (Why you may ask?  So the updated or Draft set of Q&A can be made available or open to comment while the Final set of Q&A is not.)

So for our discussion, the Draft version is more important as that represents new or updated thinking by FDA.  (Draft - https://www.fda.gov/media/163454/download)

Here are the primary items discussed in the Draft Guidance:
Sesame is now included, although this fact is not up for comment.
Ingredients and bulk ingredients used in further manufacturing must have allergen declarations.
Incidental allergens must be declared (soy lecithin, for example, used as a processing aid)
Spice and seasoning mixes must declare allergens.
Dietary supplements using roots, leaves stems and bark from tree nuts do not.
Genetic engineering - if allergen is produced, it must be stated.
Specific tree nuts must be listed - the entire list is provided.
The allergen statement as placed on the package is discussed.
The use on multipacks of food within a master pack.
Food ingredients that are derived from allergenic foods (highly refined oils, etc)
Incidental additives is discussed.
Also a section on Dietary supplements.


https://www.fda.gov/media/163454/download
Constituent Updates

Center for Food Safety and Applied Nutrition

________________________________________

FDA Issues Guidances on Food Allergen Labeling Requirements

Today, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods. Food labels are a powerful tool to help protect consumers with food allergies. Consumers can avoid ingredients they may be allergic or sensitive to in a food by looking for specific allergen labeling and reading the ingredient list.

FDA Issues Warning Letter to VA Spout Operation

FDA issued a Warning Letter to Happy Sprout Inc. of Springfield, VA after determining that the mung bean and soybean sprout products were adulterated (prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health).
  1. "Did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes.  "The cleaning and sanitizing methods that you use are not adequate to control Listeria species, as evidenced by FDA findings of Listeria species (not monocytogenes) in seven (7) environmental swabs collected during the inspection and a finished product sample collected from a retail location.""
  2. "Did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens as specified in 21 CFR 112.147 and in accordance with 21 CFR 112.144(b). You stated that you do not sample SSIW or in-process sprouts and that you were unsure if your sprouting operation has ever tested SSIW or in-process sprouts for any pathogen, including Escherichia coli O157:H7 or Salmonella spp."
  3. "Did not sanitize food contact surfaces you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts as required by 21 CFR 112.143(b). On May 23, 2022, investigators observed your sanitation practices after packaging ready-to-eat soybean sprouts. You did not apply sanitizer solution on any food contact surface. Instead, your employees rinsed equipment with water and (b)(4). Investigators observed your firm packing mung bean sprouts on May 24, 2022, without applying sanitizer prior to packing the sprouts. In addition, when an employee was asked about the frequency of sanitation activities, the employee stated that sanitizer is applied, “(b)(4).” Your General Manager also stated that while (b)(4) cleaning is conducted (b)(4), the (b)(4) is deep cleaned and sanitized"
  4. "Did not train personnel who handle (contact) covered produce or food contact surfaces, as required by 21 CFR 112.21, and personnel who conduct covered activities or who supervise personnel who handle covered produce or food contact surfaces as required by 21 CFR 112.22. For example, farm management stated that employees were trained approximately ten (10) years ago. The timeframe of (b)(4) for employee training does not meet the requirement of at least once annually, as required by 21 CFR 112.21(a). In addition, training must be conducted in a manner that is easily understood by the personnel being trained (21 CFR 112.21(c)). Your employees stated that (b)(4). Your supervisor did not demonstrate a means to communicate with employees in order to correct their food handling practices. Further, farm management stated that they have not successfully completed a food safety training at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, as required by 21 CFR 112.22(c). This deviation from the PSR was observed during a previous inspection of your firm conducted October 2-10, 2019."
  5. "Personnel at your firm did not use hygienic practices, as required by 21 CFR 112.32. Specifically:
    1. On May 23 and 24, 2022, four (4) employees handled sprouts without first washing their hands before donning single-use gloves when returning from break or handled sprouts when gloves may have been soiled.
    2. On May 24, 2022, employees handled the bottom of a bin kept on the floor and then handled sprouts without washing their hands or changing gloves.
    3. On May 24, 2022, a gloved employee picked up a hose lying on the floor, used the hose, and then rinsed their gloved hands with only water in the production room hand sink before returning to the production line to skim mung bean sprout particles from the production line water bath.
    4. On May 23, 2022, two employees were packaging sprouts wearing watches that were not covered by their gloves or clothing. An employee was wearing a dangling necklace while packaging sprouts."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/happy-sprout-inc-638237-10272022
WARNING LETTER

Happy Sprout Inc.
MARCS-CMS 638237 — OCTOBER 27, 2022
Recipient:
Hyo Young Lee
Owner
Happy Sprout Inc.
7954 Twist Lane, Unit H
Springfield, VA 22153-2823
United States

Monday, November 28, 2022

A Meat-alternative Plant Receives Scrutiny After Employee Leaks Information to Press

An employee leaked information and pictures to a news reporter regarding unsanitary conditions at facility that produces alternative-meat products.  Listeria-testing data indicated a high prevalence of Listeria in the facility, which may not be overly surprising for a facility that was once a meat operation until it was purchased to produce meat-alternative products.  While the meat-alternative products are not RTE, that is, they will be cooked, one would not expect to see this level considering the ingredients used to make the meat-alternative product.  Couple this with unsanitary procedures creates a higher risk status for the consumer.

"In a response to Bloomberg, Beyond pointed out that the plant had passed inspections by both state and federal authorities. Bloomberg, however, stated that the state “inspection” was a routine annual visit that did not include a comprehensive examination of food safety, and that the USDA said it hadn’t inspected the plant since Beyond bought it."

Food Processing Magazine
https://www.foodprocessing.com/food-safety/cleaning-sanitation-hygiene/news/21438201/report-beyond-meat-plant-had-sanitation-problems
Report: Beyond Meat Plant Had Sanitation Problems
Nov. 22, 2022

Ice Cream Recalled After Packaging Error Results in Undeclared Allergens

Weis Markets today said it has issued a recall for 108 containers of Weis Quality Sea Salt Caramel Ripple Ice Cream (48oz) since the product may contain undeclared soy and coconut allergens.  The recall was initiated after it was discovered that product containing soy and coconut was distributed in packaging that did not reveal the presence of soy and coconut. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging process.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/weis-markets-issues-allergy-alert-weis-quality-premium-sea-salt-and-caramel-ripple-ice-cream-due
Weis Markets Issues an Allergy Alert for Weis Quality Premium Sea Salt and Caramel Ripple Ice Cream Due to Undeclared Soy and Coconut Allergens
Summary
Company Announcement Date:  November 23, 2022
FDA Publish Date:  November 23, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy and Coconut Allergens
Company Name:  Weis Markets
Brand Name:  Weis Quality
Product Description:  Premium Sea Salt and Caramel Ripple Ice Cream