Sunday, May 31, 2026

FDA Issues Warning Letter to Michigan Pet Treat Manufacturer

FDA issued a Warning Letter to Best Buy Bones of Mount Morris, MI for "evidence of significant violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals".  "During the inspection, on September 9, 2025, an FDA investigator collected samples of your Nature's Own Pet Chews Bully Bites, lot 9/2027. Sample analysis revealed that the sampled lot contained Salmonella Uganda."

While the Warning Letter points out items that were bad within the operation, it also points out how the response to the Inspectional Observations as detailed in the 483 report were not adequate for providing proof to FDA that the corrective actions were adequate.  

For example, the company had not established adequate cooking procedures and attempted to correct that issue.  However, FDA stated, "You indicated that the root cause for product not reaching required time and temperature for your preventive control was due to not having established minimum operational cook times and temperatures in your Food Safety Plan, and that you need to account for variance in temperature monitors and temperature ramp times that can alter operating minimums. You indicated that you have now established minimum operational cook times and temperatures for all products in your Food Safety Plan. However, we are unable to evaluate the adequacy of your corrective actions because you have not provided supporting documentation to demonstrate that you are consistently and adequately implementing your corrective actions. For instance, you have not provided a copy of your revised Food Safety Plan and applicable monitoring records."

This is a good document to review in what FDA looks for in the company's response regarding its corrective actions.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/best-buy-bones-inc-719212-04302026
WARNING LETTER
Best Buy Bones, Inc.
MARCS-CMS 719212 — April 30, 2026

USDA FSIS Issues Health Alert for Beef Kafka As Part of Investigation into E. coli Outbreak Impacting Nine People in CA

USDA FSIS is issuing a public health alert due to concerns that beef kofta products served at The Kebab Shop restaurant locations may be contaminated with Shiga toxin-producing E. coli (STEC) O157:H7.  The beef kofta was produced as a raw ground beef product by Olympia Food Industries, Inc. dba Olympia Foods (Est. 18743) in Franklin Park, Illinois, on January 6, 2026, and supplied to The Kebab Shop restaurant locations in California, Texas, and Florida.  The problem was discovered as part of an ongoing illness outbreak investigation. FSIS, the California Department of Public Health (CDPH), and local health departments in California are investigating a localized outbreak of E. coli O157:H7 that includes 9 sick people in California. As of May 24, 2026, illness onset dates have been reported ranging from March 27, 2026, to April 30, 2026. 

A recall was not issued because the product is no longer for sale.

Comment: Beef kofta is a Middle Eastern dish made from ground beef combined with onions, garlic, fresh herbs and aromatic spices.  The mixture is shaped into cylindrical logs, patties, or meatballs, sometimes skewered, and cooked and grilled.  The product is grilled in a way that it is still juicy, so the tendency would be towards undercooking versus overcooking, so this is where E. coli survival poses a greater risk.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-beef-kofta-products-served-kebab-shop-restaurant
FSIS Issues Public Health Alert for Beef Kofta Products Served at The Kebab Shop Restaurant Locations Due to Possible E. Coli O157:H7 Contamination

WASHINGTON, May 24, 2026 - The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that beef kofta products served at The Kebab Shop restaurant locations may be contaminated with Shiga toxin-producing E. coli (STEC) O157:H7. A recall was not requested because the products are no longer available for purchase.

Thursday, May 28, 2026

NJ Firm Recalls Ice Pops After FDA Determines Allergen Cross-Contact Issues in Manufacturing Processes

DE DIOS’S ICE POPS II LLC, Patterson, NJ, is voluntarily recalling its 3.7 oz. packages of “popsicles” food treats because they may contain undeclared MILK, YELLOW #5, RED #40, PECANS, AND PISTACHIOS.  The recall was initiated after an FDA inspection revealed that existing manufacturing processes required improvements to prevent allergen cross-contact. DE DIOS’S ICE POPS II LLC has immediately implemented corrected processes and new instructions as directed by the FDA to ensure the safety of all future production.

Comment:  A bad day when FDA has to tell you that you are not doing a good job with allergen control.  This is where a good facility audit, either or both an internal audit and 3rd party audit should be used to identify these issues.

The recalled products are labeled under the dba: D’DIOSES FRUIT POPS. They were distributed to retail grocery stores in the following states: [N.J., N.Y., P.A., C.T.].


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/de-dioss-ice-pops-ii-llc-issues-allergy-alert-undeclared-milk-pecans-pistachio-yellow-5-and-red-40
DE DIOS’S ICE POPS II LLC Issues Allergy Alert on Undeclared Milk, Pecans, Pistachio, Yellow #5, and Red #40 in Popsicles
Summary
Company Announcement Date:  May 27, 2026
FDA Publish Date:  May 27, 2026
Product Type:  Food & Beverages
Reason for Announcement:  May Contain undeclared milk, pecans, pistachios, yellow #5 and red #40
Company Name:  De Dios’s Ice Pops II LLC
Brand Name:  D’Dioses
Product Description:  Fruit popsicles

Chocolate Candy Recalled After Mispackaging Results in Undeclared Peanut

Bazzini, LLC, of Allentown, PA, a co-manufacturer utilized by SkinnyDipped®, is voluntarily recalling a limited number of cases of SkinnyDipped® Dark Chocolate Coconut Almond Bites, out of an abundance of caution, due to the possible presence of undeclared peanut allergen.   The recall is being issued after a consumer reported allegedly finding peanut butter containing products in SkinnyDipped® Dark Chocolate Coconut Almond Bites individual wrappers within the 3.17oz. 10-count package. Peanuts and peanut butter are not intended ingredients in SkinnyDipped® Dark Chocolate Coconut Almond Bites

Comment: This appears to be a mispackaging issue where a peanut butter containing product was put into a Dark Chocolate Coconut Almond Bite.   This is also a co-manufactured item.  We often get questions regarding the degree to which a brand owner needs to be involved with a co-manufacturers development and implementation of policies and procedures, including the Food Safety Plan.  I always err to the side of paranoia.

The recalled products were distributed nationwide and sold through retailers.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bazzini-voluntarily-recalls-certain-lots-skinnydippedr-dark-chocolate-coconut-almond-bites-due
Bazzini Voluntarily Recalls Certain Lots of SkinnyDipped® Dark Chocolate Coconut Almond Bites Due to Undeclared Peanut Allergen
Summary
Company Announcement Date:  May 27, 2026
FDA Publish Date:  May 27, 2026
Product Type:  Food & Beverages
Reason for Announcement:  May Contain undeclared peanuts
Company Name:  Bazzini, LLC
Brand Name:  SkinnyDipped
Product Description:  Dark Chocolate Coconut Almond Bites

Sunday, May 24, 2026

CA Specialty Beverage Company Recalls Various Products Due to Potential Salmonella, Another Recall Linked to Suspect Dry Milk Powder Supply Issue

SKS Copack of Cerritos, CA is recalling various specialty beverages, because they have the potential to be contaminated with Salmonella.  The recall was initiated after SKS Copack received notification from its supplier regarding a voluntary recall initiated by California Dairies, Inc. for a certain lot of low heat nonfat dry milk powder due to possible Salmonella contamination. 


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sks-copack-recalls-various-specialty-beverages-because-possible-health-risk
SKS Copack Recalls Various Specialty Beverages Because of Possible Health Risk
Summary
Company Announcement Date:  May 22, 2026
FDA Publish Date:   May 23, 2026
  Type:  Food & Beverages
Reason for Announcement:  Due to contamination of Salmonella
Company Name:  SKS Copack
Brand Name:  Angel Specialty Products, Royal Gold, Boba Time, Fanale, Denda
Product Description:  Specialty Beverages

NJ Raw Pet Food Company Recalls 6 Months of Product Due to Listeria

Raaw Energy, Howell, NJ, is recalling all its dog food products manufactured between 7/17/25 and 12/23/25 and one lot from 3/31/26 after 4 samples tested positive for Listeria monocytogenes and other pathogens.  Sampling and testing was conducted by New Jersey Department of Agriculture.  Since the original issuance of this advisory in January 2026, the FDA has received additional consumer complaints of illness in animals who have consumed recalled product.

This information is listed on the companies website:  
(https://raawenergy.com/bacterial-control-procedures/)
Bacterial control procedures
Every day, our machines are cleaned, washed, rinsed, and sanitized.

All bags used to package meat are sanitized before they’re filled.

Food is ordered and processed promptly to minimize time out of temperature control, so it’s frozen and ready for use as quickly as possible.

Our team is trained on cleanliness standards, and we take time to educate every employee on safe handling practices and how bacteria can grow when food isn’t handled properly.

We also added two new pieces of equipment: a sanitizer system and a commercial steam cleaner. Common areas like the break room and bathrooms (and other high-traffic areas) are misted with sanitizer daily.

The steam cleaner helps us reach tight spots and small crevices that are hard to clean thoroughly by hand.

We source human-grade ingredients, and our products are tested for bacteria before they reach us.

This page is here to reassure anyone who has questions about the quality and handling standards at Raw Energy.

We work hard to deliver a clean, consistently handled product—without cutting corners on price, delivery, packaging, processing, or blend availability. If you ever want to see how we do things or have questions, we’re happy to walk you through our process.

Comment:  There is no apparent bacterial reduction on the main source of pathogens, the raw meat.  And verification testing is not mentioned.  One can say its clean, but how do you know. 


https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-advisory-do-not-feed-eight-lots-raaw-energy-dog-food-due-contamination-harmful-bacteria
FDA Advisory: Do Not Feed Eight Lots of Raaw Energy Dog Food Due to Contamination with Harmful Bacteria
As of May 2026, the number of recalled lots has risen to more than 180.

Thursday, May 21, 2026

FDA Provides Resource on Conducting a Root Cause Analysis and Other Best Practices

FDA issued an important resource for industry on how to conduct a Root Cause Analysis (RCA).  Conducting a root cause analysis when there is a food safety incident is critical in finding the cause or source of that incident so that that it can be prevented.

A root cause analysis is required as part of a companies corrective action procedures.


FDA provides links to their involvement with industry partners on other best practices.
https://www.fda.gov/food/food-industry/food-safety-best-practices-human-foods



https://www.fda.gov/food/outbreaks-foodborne-illness/strengthening-food-safety-through-root-cause-analysis
Strengthening Food Safety through Root Cause Analysis

FDA Issues Warning Letter to Airline Catering Operation

FDA Issued a Warning Letter to a Austrian based airline caterer with operations in the United States (New York and Detroit) citing significant sanitation issues and widespread concerns with Listeria findings in RTE finished products and on direct food-contact surfaces in several facilities.

This is a lengthy report that cites numerous GMP issues and the lack of Listeria control, but to note, FDA stated "In [the] New York facility, ten (10) FDA environmental swabs were positive for L. monocytogenes during the 2025 inspection in areas in close proximity to food contact surfaces and in high-traffic areas, including, legs of a processing area table, floor surfaces within processing areas, floor surfaces beneath cooling units, a tilt skillet leg, and the wheels of rolling racks."

Certainly makes you rethink eating food during flights.  Good thing for those of use stuck in the cheap seats, we only get packaged pretzels.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/doco-aktiengesellschaftdoco-inc-717773-03302026
DO&CO Aktiengesellschaft/DO&CO, Inc.
MARCS-CMS 717773 — March 30, 2026

FDA Issues Warning Letters to Importers for Issues with FSVP

FDA issued a Warning Letter to four food importers for FSVP failures. Importers of food must comply with FSVP requirements.

Great One Trading Inc., Brooklyn, NY
MARCS-CMS 728716 — April 24, 2026
Did not develop an FSVP for any of the foods imported, including each of the following foods:
Fresh Soy Chip imported from (b)(4) located in (b)(4).
White Lotus Seed Paste w/Yolks Mooncake imported from (b)(4), located in (b)(4).
Sesame Tapioca Cracker imported from (b)(4), located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/great-one-trading-inc-728716-04242026

Sahara Enterprise Inc. Philadelphia, PA
Did not develop an FSVP for any of the foods imported, including each of the following foods:
1. DRY DOUGH MIX (phyllo dough) imported from (b)(4), located in (b)(4).
2. CANDY (Turkish delight) imported from (b)(4), located in (b)(4).
3. BAKLAVA imported from (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sahara-enterprise-inc-728927-04292026

Baja Fresko Distributors Inc.Norco, CA 92860
MARCS-CMS 725781 — March 27, 2026
Did not develop an FSVP for any of the foods Imported, including each of the following foods:
(b)(4) Squash, imported from, (b)(4), located in (b)(4)
Cucumbers, imported from, (b)(4), located in (b)(4)
Husk Tomatoes imported from, (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baja-fresko-distributors-inc-725781-03272026

JMT Inter LLC Middletown, DE
MARCS-CMS 718661 — February 19, 2026

From the report:  "During our inspection, you indicated you choose to comply with the requirements for very small importers and may meet the definition of a “very small importer” under 21 CFR 1.500. If you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of a very small importer as required per 21 CFR 1.512(b)(1)(i). You are also still required to comply with the requirements in sections 1.502, 1.503, and 1.509. However, you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (see 21 CFR 1.512(b)(3)(i))."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jmt-inter-llc-718661-02192026

FDA Issues Warning Letter to Oregon Farming Operation

FDA issued a Warning Letter to Naumes, Inc., a farming operation in Medford, OR.  The inspection resulted in FDA’s issuance of a Form FDA 4056 (FDA 4056), Produce Farm Inspectional Observations, listing the observations at the farm.

Main items identified:
  • "Did not manage water used during harvesting, packing, or holding covered produce as necessary to maintain its safe and adequate sanitary quality, as required by 21 CFR 112.44(d)(1).  On September 15, 2025, our investigator observed wooden pear harvest bins being submerged in recirculated, municipal water in dump tanks. The investigator observed several harvest bins to have grass and vegetative debris stuck to the bottom causing the surface of each dump tank to have vegetative debris floating on top." 
  • FDA" observed pear harvest bins placed directly on the ground during harvest at the Bragg Orchard. When full bins were picked up in the orchards, using pack forks, clumps of grass and vegetative debris were stuck to the bottom of some bins. The investigator observed grass and vegetative debris contacting pears on at least 4 bin stacks at Bragg Orchard."
  • FDA "observed that the annual water risk assessment for EVO orchard documented the use of overhead irrigation where water makes direct contact with pears within three days before harvest. The assessment also determined that the rest of the orchards are irrigated using micro sprinklers that are not intended to contact covered produce; however, low-hanging fruit or foliage may be positioned within the spray pattern."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naumes-inc-719653-01212026
WARNING LETTER
Naumes, Inc.

MARCS-CMS 719653 — January 21, 2026