FDA Warning Letters Issued to Food Importer for FSVP - Jan/Feb 2024 Edition

FDA issued Warning Letters to several food importers.  While three of the five were the same old thing, no FSVP for importer food, the other two had FSVP programs (for some items) but these programs were improperly designed and/or implemented.

FDA Issues Warning Letter to Iowa Egg Facility

In June of 2023, the Iowa Department of Agriculture, under contract with the Food and Drug Administration (FDA), inspected Iowa Egg Company Inc.'s Osage, IA shell egg farm and egg processing facility, where eggs are washed, graded, and packed.

FDA cited a number of issues where the company was not meeting the requirements.  

• "Did not have and implement a written 'compliant' Salmonella Enteritidis (SE) Prevention Plan that includes, at minimum, the SE prevention measures required by 21 CFR118.4.   Had a plan, but was not viewed as compliant."
• "Did not have written measures to ensure that there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b). Inspectors observed gaps for potential entry of pests and other animals to the poultry houses (including large gaps in the (b)(4) house), perimeter exhaust fans missing their protective cages, and other fans with protective cages that were not securely fastened."
• "Did not adequately monitor pest activity - the bait consumption was not routinely monitored. Inspectors observed evidence of rodent activity, including droppings and chewed insulation in the (b)(4) house and did not routinely monitor fly activity, did not identify a threshold for acceptable and unacceptable fly activity, and did not identify corrective actions to take if unacceptable activity was observed. Further, flies were observed in the (b)(4) house."
• "SE Prevention Plan did not include cleaning and disinfection procedures for poultry houses, in the event that you have an environment test or egg test that was positive for SE at any point during the life of a flock, as required by 21 CFR 118.4(d)."
• "Did not hold or transport eggs at or below 45°F ambient temperature beginning36 hours after the time of lay, as required by 21 CFR 118.4(e). Your SE Prevention Plan stated “eggs should be stored in a cooler that is (b)(4)”; however, your cooler temperatures routinely exceeded 45°F. For example, from May 4, 2023, through June 4, 2023, the documented cooler temperatures ranged from 51°F to 68°Fconsecutively for 31 days."
• "Did not conduct environmental testing for SE in your poultry houses when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, the (b)(4) house and the (b)(4) house were tested when the flocks were approximately 48 weeks of age."
• "Did not maintain records regarding your SE Prevention Plan in accordance with the requirements set forth by 21 CFR 118.10."

We take egg safety for granted when we cook those sunny-side up or over easy eggs.  However, if Salmonella is not controlled, these low cook methods may not be sufficient for eliminating a high level of Salmonella.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/iowa-egg-company-inc-663904-12152023
Iowa Egg Company Inc.
MARCS-CMS 663904 — DECEMBER 15, 2023

Frying Oil - Quality and Safety Considerations

An article in Food Technology magazine, Ensuring Quality and Safety in Fried Foods, provides basic principles for maintaining frying oil quality and ensuring safety. Many types of foods are fried in oil and these frying operations can occur in all sectors of the food supply chain - large food facilities. restaurant and food service establishments, non-profit fund raising operations, and consumer's home fryers. Frying oils are probably not given much thought until we eat something where that oil has become rancid, giving the food a nasty taste. Other issues for food safety include under-processed/undercooked product and product subject to allergen cross contact.

Additional Recalls Announced as Processors Determine Usage of Recalled Cheese in Products

Two more recalls issued in response to the Rizo-López Foods, Inc. recall of cotija cheese.   Both of these recalls coming a week after Rizo Lopez Foods issued their recall of February 6, 2024.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bristol-farms-recalls-chicken-taco-kit-because-possible-health-risk
Bristol Farms Recalls Chicken Taco Kit Because of Possible Health Risk
February 14, 2024- Bristol Farms is recalling Chicken Taco Kit 9oz, Sell by 1/18/24, because the Chipotle Crema sauce cup has the potential to be contaminated with Listeria monocytogenes. The Chipotle Crema sauce cup in Chicken Taco kit was manufactured using the Rizo-López Foods, Inc recalled Cojita cheese.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mg-foods-voluntarily-recalls-ham-cotija-torta-sandwich-distributed-florida-due-possible-listeria
Mg Foods Voluntarily Recalls Ham & Cotija Torta Sandwich Distributed in Florida Due to Possible Listeria Monocytogenes Contamination of Cotija Cheese
Melbourne, Fla. (February 13, 2024) - MG Foods is voluntarily recalling a Ham & Cotija Torta Sandwich on Telera Roll sold in Florida. This voluntary recall is being initiated as a result of the Rizo-López Foods, Inc. recall of cotija cheese

Pathogenic E. coli Outbreak with Ten Illnesses Linked to Raw Milk Cheddar Cheese

CDC and FDA are investigating an E.coli outbreak linked to raw cheddar cheese.  "As of February 16, 2024, a total of 10 people infected with the outbreak strain of E. coli have been reported from four states [CA - 4, UT - 2, CO - 3, and TX - 1]. Illnesses started on dates ranging from October 18, 2023, to January 29, 2024 (see timeline). Of 9 people with information available, 4 have been hospitalized and 1 developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. No deaths have been reported.

•  Of the 8 people interviewed, 6 (75%) reported eating RAW FARM brand raw cheddar cheese.
• WGS showed that bacteria from sick people’s samples are closely related genetically. This suggests that people in this outbreak got sick from the same food.
• No product samples consumed by consumers or products available for sale have tested positive for E.Coli 0157:H7.
• Raw Farm, of Fresno CA is voluntarily recalling selected date codes of Raw Cheddar Cheese.

Because raw milk cheese is not pasteurized, the heat step is not present that would eliminate pathogens such as E. coli STEC.  Rather, aging along the presence of lactic acid bacteria (LAB) are counted on.

Biological control of pathogens in artisanal cheeses - https://www.sciencedirect.com/science/article/pii/S0958694623000316

From the Raw Farm website ( https://rawfarmusa.com/) 

TESTED.

We are deeply committed to the safe production of high-quality raw dairy products. We proudly meet and EXCEED all required California state testing and #dodairydifferent with our unique Test & Hold Protocol that tests for pathogens. 

Of course testing your way to safety is not full proof.

CDC Food Safety Alert
https://www.cdc.gov/ecoli/raw-milk-cheese-2-24/index.html
E. coli Outbreak Linked to Raw Milk Cheese
Posted February 16, 2024

Fast Facts
Illnesses: 10
Hospitalizations: 4
Deaths: 0
States: 4
Recall: Yes
Investigation status: Active

Contaminated Food
RAW FARM brand raw cheddar cheese
Flavors include original and jalapeno
All sizes of blocks and shredded packages
Sold nationwide
Raw Farm LLC has agreed to recall products and is working with FDA

Purchasing Changes Ingredient But Misses Need to Update Label for Sesame

Capitol Distributing of Caldwell, Idaho is recalling 3,934 sandwiches because they may contain undeclared sesame.  Prepared turkey and cheese sandwiches included sesame that was not declared on the product label. Potential cross contact occurred when chicken salad on a croissant and egg salad sandwiches were prepared on the same surface as the turkey sandwiches.   A new bread source for sandwiches included sesame and the allergen was incorrectly left off of updated sandwich labels. The labels have been updated and any future possibility of cross contact has been eliminated.

The products were distributed in Arizona, California, Idaho, Nevada, Oregon, Utah and Washington. 

So what should have happened in the purchasing process to prevent this type of issue? Have an approval process for ingredients prior to purchase to ensure food safety parameters including allergens.  Linked to that, have ingredient specifications that identify risks needing controls including allergens..   Also, training those tasked with purchasing products on  food safety related issues including allergens in the ingredients being purchases AS WELL AS allergens handled by the supplier that may impact the ingredient purchased.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/capitol-distributing-issues-allergy-alert-undeclared-sesame-product
Capitol Distributing Issues Allergy Alert on Undeclared Sesame in Product
Summary
Company Announcement Date:  February 15, 2024
FDA Publish Date:  February 15, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame
Company Name:  Capitol Distributing
Brand Name:  CK, Jacksons
Product Description:  Turkey and cheese sandwich, egg sandwich, chicken salad on a croissant

FL Establishment Recalls RTE Processed Meat Products After State Testing Finds Listeria

Don Novo & Son, a Miami, Fla. establishment, is recalling approximately 9,330 pounds of ready-to-eat (RTE) meat products that may be adulterated with Listeria monocytogenes.  The products subject to recall bear establishment number “EST. 34257” inside the USDA mark of inspection. These items were shipped to retail locations in Florida.  The problem was discovered when FSIS was notified that a sample collected by a state public health partner tested positive for the presence of L. monocytogenes.  There have been no confirmed reports of adverse reactions due to consumption of these products.

https://www.fsis.usda.gov/recalls-alerts/don-novo-son-recalls-ready-eat-meat-products-due-possible-listeria-contamination
Don Novo & Son Recalls Ready-To-Eat Meat Products Due to Possible Listeria Contamination

WASHINGTON, Feb. 15, 2024 – Don Novo & Son, a Miami, Fla. establishment, is recalling approximately 9,330 pounds of ready-to-eat (RTE) meat products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FDA Issued Warning Letter to Indiana Bakery for Sesame Control Issue

FDA issued a Warning Letter to an Indiana bakery that did not have proper label controls in place for sesame.  The inspection was triggered by a reported illness.

• The firm recalled “Our Family” brand White Hot Dog Enriched Buns on March 21, 2023 after it was discovered that the product contained sesame, but the printed packaging did not declare sesame. The firm became aware of the undeclared sesame after being notified by a customer of an allergic reaction to sesame after a child consumed the buns.
• The owner indicated that the firm reformulated “Our Family” brand White Hot Dog Enriched Buns in January 2023 by adding sesame to the formulation. On February 9, 2023, the facility received printed plastic packaging for the buns which did not declare sesame in the ingredients statement. Between February 9, 2023 and March 20, 2023, the facility manufactured the “Our Family” brand White Hot Dog Enriched Buns using the incorrect label, which resulted in undeclared sesame in the product.
• On March 28, 2023, the company provided documents which indicated that they determined the root cause to be a “lack of label control,” as the receiver accepted incorrect packaging into the plant and the bagger operator used incorrect packaging that did not contain the correct allergen labeling. Owner stated that the action plan includes retraining “bag operators, break people, and supervisors” to check for correct allergen labeling “before being used at point of use”; updating policy to include the “QA manager or designated back-up visually verifying and documenting every receipt of bags before they can be received in (b)(4) and put in the warehouse”; creating a policy that future allergen labeling changes will require a new bag number, “making it impossible to receive old bag into plant”; and creating policy that will require new packaging proofs to be signed off by your company before new packaging can be printed. 
• FDA stated they will verify implementation of any corrective actions during FDA’s next inspection of the facility.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/perfection-bakeries-inc-dba-aunt-millies-bakeries-657559-09072023

WARNING LETTER

Perfection Bakeries Inc., dba Aunt Millie’s Bakeries
MARCS-CMS 657559 — SEPTEMBER 07, 2023

CA Processor of Fresh Noodle Product Issued Warning Letter for Everything...Close to Everything

FDA issued a Warning Letter to Lucky K.T. Co., Inc of El Monte, CA a processor of Fresh Rice Noodle and Rice Stick Noodle food product.

It is a huge Warning Letter, so in quick summary:

• Did not have a food safety plan with the required elements for any of the products manufactured at the  facility.
• Did not have proper controls in place for a cooked RTE product (w/pH > 4.6 and Aw close to 0.99) that could potentially support the growth of sporeforming pathogens such as B. cereus and C.botulinum.  Specifically time/temperature controls.
• Did not develop and implement controls for allergens or mycotoxins.
• A huge list of GMP violations were noted.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lucky-kt-co-inc-659663-01262024
WARNING LETTER

Lucky K.T. Co., Inc.
MARCS-CMS 659663 — JANUARY 26, 2024