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. 

Bonami Bakery – Bay Area Bakery Shop (thebonamibakery.com)

FDA Warning Letter

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Here are the primary items discussed in the Draft Guidance: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

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

QA Director Pleads Guilty to Concealing Conditions That Lead to Salmonella Outbreak Linked to Cereal

A QA Director has pleaded guilty for concealing food facility conditions that led to a Salmonella outbreak where 130 people were infected. "Ravi Chermala overlooked unsanitary conditions that led to the Salmonella outbreak linked to Kellogg's Honey Smacks cereal in 2018.

From the Justice report, "Ravi Kumar Chermala, 47, pleaded guilty to three misdemeanor counts of causing the introduction of adulterated food into interstate commerce. Chermala, Kerry’s Director of Quality Assurance until September 2018, oversaw the sanitation programs at various Kerry manufacturing plants, including a facility in Gridley, Illinois, that manufactured Kellogg’s Honey Smacks breakfast cereal for Kerry’s customer, the Kellogg Company. In pleading guilty, Chermala admitted that between June 2016 and June 2018, he directed subordinates to not report certain information to Kellogg’s about conditions at the Gridley facility. In addition, Chermala admitted that he directed subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions."

Don't be this guy.


https://www.foodprocessing.com/food-safety/news/21438121/former-kerry-qa-director-pleads-guilty-in-2018-salmonella-outbreak-from-kelloggs-honey-smacks-cereal
Former Kerry QA Director Pleads Guilty in 2018 Salmonella Outbreak
Nov. 20, 2022

Ravi Chermala overlooked unsanitary conditions that led to Kellogg's Honey Smacks cereal recall and 130 illnesses.

Just Another Recall for Enoki Mushrooms After MI Lab Detects Listeria

Green Day Produce, Inc. of Vernon, CA is recalling its 200g/ 7.05oz packages of ENOKI MUSHROOM (Product of Korea) sold from September 2022 - October 2022 because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was discovered after a retail sample was collected and analyzed by Michigan Department of Agriculture and Rural Development (MDARD) and revealed the presence of Listeria monocytogenes in 200g/7.05 oz. package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-day-produce-inc-recalls-enoki-mushrooms-because-possible-health-risk
Green Day Produce, Inc. Recalls Enoki Mushrooms Because of Possible Health Risk
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria Monocytogenes
Company Name:  Green Day Produce
Brand Name:  Green Day Produce
Product Description:  Enoki Mushrooms

Wheat-free Power Pancakes Recalled for Containing 1% Wheat

Phil’s Power Pancake of Costa Mesa, CA is recalling its 5 oz. packages of individually wrapped Power Pancakes in all 5 varieties (Mango, Raspberry, Cranberry, Dates, and Chocolate Chip Hempseed) because they may contain undeclared wheat.  All 5 varieties of pancakes contain rye flour that contains 1% wheat. Labels on the product distributed state “wheat free” and new labels will read “99% wheat free”.

1) That 1% present does not allow one to say 'free' from that.

2) Power pancakes are a thing.....just have to douse them with plenty of maple syrup I guess to get them to slide on down.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/phils-power-pancake-issues-allergy-alert-undeclared-wheat-phils-power-pancake
Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 18, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Phil’s Power Pancake
Brand Name:  Phil’s Power Pancake
Product Description:  Pancakes in 5 varieties (mango, raspberry, cranberry, dates, chocolate chip hempseed