FDA Issues Warning Letter To Candy Company - Allergen Control Issues and GMPs

FDA issued a Warning Letter to a chocolate company highlighting allergen control and other GMP issues.   This recall highlights the concern when a supplier has not controlled allergens in their product, and even states that, but the processor uses that ingredient anyway.  We are seeing this more often, when a supplier puts a precautionary statement on the ingredient which is purchased....then that issue becomes the purchasing company's issue.
Internally, the company's allergen control program was not implemented properly.

The inspection was started after an allergen complaint where someone reacted to a milk allergen in dark chocolate.

"The inspection was initiated in response to a consumer complaint regarding an allergic reaction and subsequent sampling conducted by FDA, which revealed elevated levels of milk protein in your Ultra Dark Chocolate Amaretto Rainier cherries"

This issue was primarily due to a supplier issue where milk was present in the dark chocolate where the purchasing company did not have milk listed.

"Although milk is not used as an ingredient in your dark chocolate covered nut and fruit products.   FDA found elevated levels of milk protein in these products.  Further, FDA found elevated levels of milk protein in the chocolate ingredients you use to produce your dark chocolate covered nut and fruit products.  These chocolate ingredients do not include milk as an ingredient.  Subsequently, you conducted voluntary recalls for the finished product lots associated with the FDA samples."

First, the company did not recognize this supply issue in the hazard analysis, even though the supplier stated it could be an issue.

"Your hazard analysis did not identify the unintentional presence of milk allergens as a hazard requiring a supply-chain applied control in the bittersweet, (b)(4) chocolate you obtain".....The need to consider milk allergens as a hazard requiring a supply-chain-applied control was highlighted by your supplier’s allergen policy indicating the possible presence of undeclared milk allergens.  Specifically, your supplier’s policy states that “dark items that do not have milk intentionally added as an ingredient may contain milk from cross contact due to processing on shared equipment.”

Once the company became aware of the issue, they did not revise their Preventive Control Plan.

"You became aware of new information when you received a consumer complaint regarding an allergic reaction to your Ultra Dark Chocolate Amaretto Rainiers (Best By 09/2019) and subsequent test results from a third-party laboratory and FDA.  Specifically, you received results from the third-party laboratory indicating the presence of milk protein in the finished product and raw ingredients on September 14, 2018, and September 19, 2018.  Subsequently, you received finished product sample results from FDA indicating the presence of milk protein at levels as high as 7000 ppm in your covered nut and fruit products.  You also received FDA test results of the chocolate that you obtained from your supplier indicating milk protein levels as high as 4300 ppm.  However, after receiving these results, you did not conduct a reanalysis of your food safety plan dated September 12, 2018, to consider whether food allergens are a hazard requiring a supply-chain-applied control."

And they did not determine what activities needed to be in the Supply Chain Preventive Control.

"You did not determine and conduct appropriate supplier verification activities,"

The company had internal issues as well:
4.  The company stated they would put a schedule run process in place to run products with specific allergens, but did not follow this run schdule.

"You did not implement a preventive control, as required by 21 CFR 117.135(a).  Specifically, your food safety plan dated September 12, 2018, contains the preventive control of “run order of allergenic materials” for the food safety hazard of “food allergens from other products."

5. Mishandling of rework that leads to cross contact
6. Did not conduct visual inspection for allergen control

"our investigators observed apparent chocolate powder and residue on the outside and inside of the air vents for pan #(b)(4) and #(b)(4).  These vents are used to blow air over all varieties of chocolates including milk, tree nut, and non-milk, non-tree nut products, which could cause cross contact of milk and tree nuts in products that do not contain milk and tree nut ingredients during the (b)(4) process.  ​​​​​​​And  b.    On November 7, 2018, our investigators observed apparent chocolate residue on the pouch machine within approximately three inches of open pouches of a non-chocolate product....", 

7. Did not document the monitoring of  allergen control cleaning processes

"..your food safety plan identified environmental monitoring as a verification activity for your sanitation preventive controls.  However, you did not implement an environmental monitoring program."  

8. Did not "verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens."

9. Employees were not washing hands
10. No backflow prevention devices.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chukar-cherry-company-inc-573446-06272019
Chukar Cherry Company Inc. 
MARCS-CMS 573446 — Jun 27, 2019

Bison Ground Meat Recalled After Linked to Pathogenic E. coli Outbreak

Northfork Bison Distributions Inc., a Quebec Canada based company, is recalling its ground bison, referred to as Bison Ground, and its ground bison patties, referred to as Bison Burgers and/or Buffalo Burgers, produced between February 22 and April 30, 2019 due to potential linkage to an foodborne illness outbreak of E. coli O103.  This outbreak has affected 21 people with 8 hospitalizations.

The bison meat is under FDA, not USDA jurisdiction.*

If frozen patties, there is always the concern for under cooking, especially when people do not use a thermometer to verify the product is properly cooked (160F internal temp).

Interesting, the cooking instructions do not specifically say that the meat has to be cooked to 160F...unless I missed it.  Cooking temperatures are listed on the website, but going through the blog, there is certainly a miss for cooking (https://www.northforkbison.com/best-bison-burger-tips) as well as their video (https://www.youtube.com/watch?v=TjzZOgXyAw0) which when you add foie gras, the temperature should technically be 165F.

*  From USDA website

How is bison inspected?
Bison may be inspected under voluntary federal inspection or FDA equivalent inspection. FDA equivalent inspection includes state inspection. Under voluntary federal inspection by USDA's Food Safety and Inspection Service (FSIS), businesses pay an hourly rate for inspection services. Voluntary inspection is handled under the Agriculture Marketing Act, which gives the Secretary of Agriculture the authority to take whatever steps are necessary to make the product marketable.
Federal inspection is done on a carcass-by-carcass basis by FSIS. The FSIS inspector must have knowledge about that particular species and the carcass must fit available equipment in the plant. Each bison and its internal organs are inspected for signs of disease. The triangle shaped "U.S. Inspected and Passed" seal ensures the bison is wholesome and free from disease. Note: Some states require all exotic animals be inspected in order to be sold in commerce.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-linked-ground-bison-northfork-bison-distributions-july-2019
Outbreak Investigation of E. coli Linked to Ground Bison from Northfork Bison Distributions, July 2019
Consumers should avoid recalled Northfork Bison Distributions, Inc. ground bison and bison patties/burgers imported from Canada

Case Counts
Total Illnesses: 21
Hospitalizations: 8
Deaths: 0
Last illness onset: June 18, 2019
States with Cases: CT, FL, MI, MO, NJ, NY, PA

Hummus Recalled by TX Establishment After FDA Finds Listeria in Production Facility

Pita Pal Foods, LP of Houston, TX is recalling certain hummus products made between May 30, 2019 and June 25, 2019, after FDA identified Listeria in the manufacturing facility (not in finished product) during an FDA inspection.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pita-pal-foods-lp-recalls-various-hummus-and-dips-due-possible-health-risk
Pita Pal Foods, LP Recalls Various Hummus and Dips Due to Possible Health Risk
Summary
Company Announcement Date: July 15, 2019
FDA Publish Date: July 16, 2019
Product Type:Food & Beverages
Reason for Announcement:  Due to potential Listeria monocytogenes
Company Name: Pita Pal Foods, LP
Brand Name:  Bucee’s, Fresh Thyme, Harris Teeter, other
Product Description:  hummus products

Growers Express Expands Recall of Fresh Processed Vegetable Product After Additional Listeria Positive

Growers Express is expanding its original recall of frozen vegetables posted on July 1 originating from their Biddeford Maine production facility.   The release states, "After further testing of an additional product lot from the suspected source of the recall, a single retail sample was found to be positive for Listeria monocytogenes. The company has expanded the list of recalled products to include certain specific fresh Brussels sprouts, fresh cauliflower florets and fresh green beans products with the “best by” or “pack dates” identified in the chart below."

So basically, they held four days of production (Best by 6-26 to 6/29) thinking they had captured the issue, but after testing, they found an additional positive sample in a different production lot.  Being that they found one positive, one would guess that this indicates that the contamination level is low.   This is a challenge with Listeria contamination.....a small amount getting into production of product, probably a  difficulty-to-find point source that contributes a few cells throughout production.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/growers-express-expands-voluntary-recall-select-fresh-vegetable-products-due-potential-contamination
Growers Express Expands Voluntary Recall of Select Fresh Vegetable Products Due to Potential Contamination of Listeria monocytogenes

Michigan Establishment Recalls Frozen Meatloaf Due To Complaint of Metal Bits

Ada Valley Gourmet Foods, Inc., an Ada, Mich. establishment, is recalling approximately 3,490 pounds of raw ground beef meatloaf products that may be contaminated with extraneous materials, specifically broken metal bits.  The problem was discovered on July 11, 2019, when a customer notified the plant of the problem.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-073-2019-release
Ada Valley Gourmet Foods, Inc. Recalls Beef Products Due to Possible Foreign Matter Contamination
Class I Recall 
073-2019 
Health Risk:High 
Jul 13, 2019 

Over 100 with E. coli after Visiting Minnesota Lake on 4th

Between 120 and 150 people have become infected with pathogenic E. coli after boating on Lake Minnetonka in Minnesota. Environmental factors are the most likely source.

Star Tribune
http://www.startribune.com/at-least-140-report-sickness-after-lake-minnetonka-boating-on-july-4th/512542682/
Nearly 120 report sickness after Lake Minnetonka boating on July 4th
Five beaches in the metro area remain closed due to high bacteria
counts.
By Katy Read (http://www.startribune.com/katyread/
131074183/) Star Tribune
JULY 11, 2019 — 5:07AM

Woman Charged After Video of Her Child Licking a Tongue Depressor and Placing it Back

A woman was charged with tampering, a felony, after she posted a video of her 10 year old daughter licking a tongue depressor in the doctor's office examination room and then returning it to the same jar.  This comes after last week's ice cream tampering issues when on two different occasions, stupid people opened, licked, and replaced cartons of ice cream.

PennLive
https://www.pennlive.com/nation-world/2019/07/woman-charged-after-recording-daughter-licking-tongue-depressor-in-doctors-office-and-putting-it-back.html
Woman charged after recording daughter licking tongue depressor in doctor’s office and putting it back
7/12/19   8:17 AM

This Week in Mislabeled Product for Week Ending July 13, 2019

Consumer Allergic Reaction Triggers Recall of  Meal Bars -  PROBAR LLC of Salt Lake City, UT has initiated a voluntary recall of select flavors and lots of Meal® bars, including Chocolate Coconut, Peanut Butter Chocolate Chip, Original Trail Mix, Wholeberry Blast and Superfood Slam due to the possible presence of undeclared milk and soy allergens. PROBAR learned of the issue after receiving a complaint of an allergic reaction in a consumer after eating a PROBAR: MEAL Peanut Butter Chocolate Chip bar. Our investigation determined that an ingredient potentially contained milk and soy. To date, PROBAR has received this one report of illness.

Someone Missed that Worcestershire Sauce Contains Fish (anchovies) - .Baumer Foods, Inc. of Metairie, LA is recalling 10 oz PICS Soy Sauce, because it may contain undeclared fish   The recall was initiated after it was discovered that product was labeled as Soy Sauce without the known fish allergen but the bottle actually contained Worcestershire sauce. Worcestershire Sauce has the known allergen fish. Subsequent investigation indicates the problem was caused by a temporary oversight during the packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/probar-llc-issues-allergy-alert-undeclared-milk-and-soy-select-flavors-meal-r-bars
PROBAR LLC Issues Allergy Alert on Undeclared Milk and Soy in Select Flavors of Meal ® Bars
Summary
Company Announcement Date:  July 11, 2019
FDA Publish Date:  July 11, 2019
Product Type:  Food & Beverages  Meal Replacements
Reason for Announcement:Undeclared Milk and Soy
Company Name:PROBAR
Brand Name:PROBAR
Product Description:Multiple flavors of Meal Bars

Hamburger Buns and Hot Dog Buns Recalled Due to Potential for Hard Plastic

Flowers Foods, Inc. is voluntarily recalling hamburger and hot dog buns and other bakery products due to the potential presence of small pieces of hard plastic that may have been introduced during production.  The company initiated the recall following the discovery of small pieces of hard plastic in production equipment.No related injuries or illnesses have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flowers-foods-issues-voluntary-recall-hamburger-and-hot-dog-buns-and-other-bakery-foods-due-plastic
Flowers Foods Issues Voluntary Recall of Hamburger and Hot Dog Buns and Other Bakery Foods Due to Plastic Pieces Found in Products
Summary
Company Announcement Date: July 09, 2019
FDA Publish Date: July 10, 2019
Product Type:Food & Beverages  Bakery Product/Mix
Reason for Announcement: Potential Presence of Small Pieces of Hard Plastic
Company Name:Flowers Foods, Inc.
Brand Name: Multiple brands
Product Description:  Hamburger and Hot Dog Buns