Louisiana Bakery Issued a Warning Letter for Inadequate Allergen Controls

FDA issued a Warning Letter to Langlinais’ Baking Company, a ready-to-eat (RTE) bakery located in Lafayette, LA.  The issues found were that the company did not have allergen controls in place and did not recognize Salmonella as an issue for the RTE bakery.

The "hazard analysis did not identify and evaluate the hazard of undeclared allergens due to incorrect labeling at the packaging step to determine whether it is a hazard requiring a preventive control. [The] facility manufactures and labels products which contain wheat (e.g., French Bread and Hot Dog Buns) as well as a product which contains both wheat and milk (Sweet Roll Hamburger Buns)."  The firm "did not have such controls in place as evidenced by [the] November 2021 recall of French Bread manufactured on November 1, due to undeclared wheat. Also, during the inspection [the firm] stated that in October 2021 you manufactured the same French Bread with the same label (not declaring wheat) and distributed it to the same customer. Further, we note that your written prerequisite “Allergen Control Program” does not include monitoring, corrective action, or verification procedures to ensure control of undeclared allergens."

The firm 'did not identify and evaluate the hazard of allergen cross-contact to determine whether it is a hazard requiring a preventive control at the dough mixing and forming steps. [The firm] use butter, which contains milk, to manufacture Sweet Roll Hamburger Buns on mixing and forming equipment shared with products that do not contain this allergen (e.g., French Bread and Hot Dog Buns) on the same day. Allergen cross-contact could occur in products with different allergen profiles, without appropriate controls. Therefore, undeclared allergens due to incorrect labeling is a known or reasonably foreseeable hazard at the packaging step. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify allergen cross-contact as a hazard requiring a preventive control."

The "hazard analysis did not evaluate environmental pathogens, such as Salmonella, to determine whether they are a hazard requiring a preventive control at the cooling and packaging steps, to comply with 21 CFR 117.130(c)(1)(ii). Your facility manufactures RTE bread and roll products which are exposed to the environment after being baked and until they are packaged."

The firm did " not clean and sanitize equipment in a manner that protects against allergen cross-contact and against contamination of food and food-contact surfaces, as required by 21 CFR 117.35(a). On November 2, 2021, after a “(b)(4) clean” was conducted following production of Sweet Roll Hamburger Buns, FDA investigators observed two whole loaves of French Bread wedged between food-contact rollers on an overhead conveyor belt. FDA investigators also observed food residue on Mixer (b)(4) and on the (b)(4) dough forming equipment. This equipment is shared between Sweet Roll Hamburger Buns (which contain milk) and products which do not contain milk. Your sanitation manager had checked the equipment in this room and indicated it was “Go” on the “Post Cleaning Inspection” form."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/langlinais-baking-company-625493-03142022
WARNING LETTER
Langlinais’ Baking Company
MARCS-CMS 625493 — MARCH 14, 2022

FDA Issues Warning Letters to Two NY Importers for Not Having FSVP for Imported Food Items

FDA issued Warning Letters to two NY based importers for not having FSVP in place for the items that they import.  While they had some records required by the FSVP, these firms did not meet the requirements of FSVP.

Eli’s Manhattan Warehouse, Inc. of New York, NY did not develop, maintain, and follow an FSVP for any of the foods you import, including each the following food products: Blueberry, strawberry, cherry jams from (b)(4) located in (b)(4) Olive oil from (b)(4) located in (b)(4) Honey from (b)(4) located in (b)(4)

Agroson’s LLC, of, Bronx, NY 10474-6115 did not develop an FSVP for the following food products you import: Limes imported from (b)(4)

FDA Warning Letter Issued to Pet Food Facility for Inadequate Salmonella and Mycotoxin Controls

A pet food manufacturing facility was issued a Warning Letter by FDA for failure to adequately control two hazards associated with pet food...Salmonella and Mycotoxins.  FDA issued the Warning Letter after a series of 5 recalls associated these hazards as well as an FDA inspection.  FDA stated that the although the firm conducted "voluntary recalls to remove adulterated product from the marketplace", "recalling product does not prevent the reoccurrence of a hazard in your pet food. Recalling product is a reaction to an animal food safety system failure that has occurred. It is [the company's] responsibility to implement a robust hazard analysis and risk-based preventive controls program to prevent product adulterated with mycotoxin or Salmonella from entering the food supply."

Some of the issues cited:

• The "firm’s laboratory tested a sample of finished dog food kibble, Evolve Chicken and Rice Dog Formula (b)(4), and detected an elevated aflatoxin level of 32.7 ppb. This is an indication that [the company] failed to implement your ingredient testing preventive control Despite this, [the company] did not hold the out-of-specification dog food for determination of disposition, as required by [the] corrective actions in [the] food safety plan and SOPs. [The plan states] that any product that is determined to fall outside of [the] specifications should be placed on hold."
• The "firm failed to implement your preventive control when [the company] failed to follow the manufacturer’s mycotoxin test kit instructions, as well as [the] firm’s (b)(4) regarding sample preparation for incoming grain analysis." 
• "The Minnesota Department of Agriculture collected a routine surveillance sample of [the comany's] pet food “Sprout Sporting Dog Food” from retail and laboratory analysis detected Salmonella Johannesburg in the sample, resulting in a Class I recall described above."
• FDA inspection, investigators collected environmental swabs. Salmonella spp. was found on a compressed air nozzle, including the hose and reel, located in [the] post lethal treatment shaker screen room between Shaker Screen D and Shaker Screen E. {The] firm utilizes compressed air nozzles to blow off floors and equipment. FDA investigators observed at least two employees who were using compressed air to remove adhered food debris on equipment cause a nozzle to come in direct contact with food contact surfaces by scraping the surfaces with the nozzle."

FDA was requesting to meet and discuss what the firm's path moving forward.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunshine-mills-inc-618141-03072022
WARNING LETTER

Sunshine Mills, Inc
MARCS-CMS 618141 — MARCH 07, 2022

FDA Issues Warning Letter to Seafood Processor For Conditions that Led to Salmonella Outbreak

FDA issued a Warning Letter to a seafood processor located in Denver Colorado.  This inspection was 
"initiated as part of a multistate foodborne outbreak investigation of Salmonella Thompson (S. Thompson) illnesses linked to seafood." According to the CDC, 116 people from 14 states were infected with the outbreak strain of S. Thompson. On October 8, 2021, your firm recalled certain types of fresh seafood processed at your facility and distributed from May 2021 to October 7, 2021, because they had the potential of being contaminated with Salmonella."

"FDA laboratory analyses found the presence of the outbreak strain of S. Thompson, a human pathogen, in [the] facility. Additionally, FDA found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule)."

"Salmonella species are not endemic to seafood; therefore, FDA expects zero or non-detectable levels of Salmonella in seafood regardless of whether it is intended to be cooked before consumption or it is ready-to-eat (RTE). Salmonella in seafood is the result of human or animal fecal contamination of the harvest waters and/or fecal contamination during post-harvest handling and processing. The contamination can also be exacerbated by temperature abuse. Raw RTE seafood must have appropriate controls from harvest to consumption."

The facility had numerous issues relating to process control and sanitation.

FDA Warning Letter
Northeast Seafood Products, Inc. - 621620 - 03/24/2022 | FDA
Northeast Seafood Products, Inc.
MARCS-CMS 621620 — MARCH 24, 2022

FDA Issues Warning Letter to MD facility for Deviations from LACF Regulations

FDA issued a Warning Letter to a Maryland low acid canning facility for issues associated with the Low Acid Canned Food Regulation (LACF).  The deviations cited were focused on failures to ensure double seam integrity and failure to ensure  that the proper critical factors were maintained as part of the canning process specifically maintaining specified headspace.

The Low Acid Canned Food regulations require that the canning process, including proper filling, sealing and thermal process, are established and followed.  In sealing, there are specific parameters that must be continuously met to ensure integrity of the can.  The seal of the can, called a double seam, must be measured at regular intervals through several measurements, some of which require that the seam is taken apart as part of a tear-down procedure.  When tolerances around these measurements are not met, corrective action is required.

This company had numerous issues ranging from not doing the required amount of measurements, to out of spec measurements, to inadequate corrective action.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/treehouse-foods-inc-620320-01282022
WARNING LETTER
TreeHouse Foods, Inc.
MARCS-CMS 620320 — JANUARY 28, 2022

PA Establishment Recalls Bacon Marmalade After Not Having USDA Inspection

Update- 4/21/22 The recall was expanded to now include all products with production dates prior to April 18, 2022 and best used by dates through April 2024.

USDA announced that Firehouse Jams of Erwinna, PA is recalling its uncured bacon marmalade products because they were produced without USDA inspection.   

"The problem was discovered when FSIS was notified by the Office of Inspector General (OIG) of a complaint received through the OIG’s hotline. FSIS investigated the complaint and determined that the products were produced in an establishment that was not inspected by FSIS."

This is a common error of small companies who use a meat product without realizing they have ventured into USDA inspectional oversight. (And only a small percentage of meat used in a formulation (2% cooked) is sufficient to require inspection.)   In this case, the company, Eat This Yum, started in 2011 making jams, jellies and marmalades and selling at farmers' markets with a small percentage of the proceeds going to support the local fire company.  The company was featured by 'Oprah' and distribution expanded.  Of course with increased visibility, comes increased scrutiny.


Firehouse Jams, LLC Recalls Uncured Bacon Marmalade Products Produced Without Benefit of Inspection | Food Safety and Inspection Service (usda.gov)
Firehouse Jams, LLC Recalls Uncured Bacon Marmalade Products Produced Without Benefit of Inspection
FSIS Announcement

WASHINGTON, April 16, 2022 – Firehouse Jams, LLC, an Erwinna, Pa. establishment, is recalling approximately 709 pounds of heat-treated, shelf-stable uncured bacon marmalade products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FDA Issues Draft Guidance on Evaluation Process for Recognition of Additional Regulated Food Allergens

FDA released a draft guidance document on how additional allergens may be added to the group of major food allergens ( milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame).  The document )Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act) provides the approach for evaluating non-listed allergens including:

• The scientific factors that we generally intend to consider when evaluating the public health importance of a non-listed food allergen;
• Other information, relevant to the labeling and production of food containing the food allergen, that we generally intend to consider when evaluating the public health importance of a non-listed food allergen; and
• Our recommendations for how to identify and evaluate the body of evidence applicable to an evaluation of the public health importance of a non-listed food allergen.

A concern from a manufacturing perspective is that with the FASTER Act of 2021 which added sesame to the list of regulated food allergens, it opened the door to potential other food allergens being added to the list.  This draft guidance provides the evaluation process for this to occur.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-fda-staff-and-stakeholders-evaluating-public-health-importance-food-allergens-other
Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act

APRIL 2022

TX Establishment Expands Recall of Tortillas for Undeclared Wheat and Milk

The Salsa Texan of Flower Mound, Texas is expanding an earlier recall to include all regular and burrito sized packages of tortillas labeled as Coconut Flour Tortillas and Blended Flour Tortillas because they may contain undeclared wheat and milk. The voluntary recall was initiated after it was discovered that the tortillas were distributed in packaging that did not reveal the presence of wheat or milk.  The initial recall was issued on March 18, 2022.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/salsa-texan-issues-allergy-alert-and-recall-expansion-undeclared-wheat-and-milk-tortillas
The Salsa Texan Issues Allergy Alert and Recall Expansion for Undeclared Wheat and Milk in Tortillas
Summary
Company Announcement Date:  April 15, 2022
FDA Publish Date:  April 15, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat and milk
Company Name:  The Salsa Texan
Brand Name:  The Salsa Texan
Product Description:  Tortillas

EU Salmonella Outbreak in Chocolate Believed to be Due to Bad Buttermilk?

The EFSA (European Food Safety Authority) reports that there have been 150 cases (119 confirmed, 31 probable) of Salmonella Typhimurium infection in 9 different countries.   "Most cases are below 10 years of age and many children have been hospitalised."  As reported in an AP article, "Officials said “the processing step involving buttermilk” was identified by the company as the point of contamination for two products, chocolate eggs that normally have a surprise toy inside and bite-sized praline chocolates. National authorities have previously named the involved company as the Italian chocolate firm Ferrero."

https://www.ecdc.europa.eu/en/news-events/rapid-outbreak-assessment-multi-country-salmonella-outbreak-linked-chocolate-productsEuropean Centre for Disease Prevention and Control
Rapid outbreak assessment: Multi-country Salmonella outbreak linked to chocolate products

On 12 April 2022, ECDC and EFSA published a rapid outbreak assessment on a multi-country outbreak of monophasic Salmonella Typhimurium linked to chocolate products made at a factory in Arlon, Belgium.

The assessment outlines the rapid evolvement of the outbreak. Most cases are children under 10 years of age, with many being hospitalised.