FDA issues warning letters over allergen labeling failures and sanitation concerns

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Knickerbocker 365 Inc.
Madison Heights, MI

The U.S. Food and Drug Administration has issued a warning letter to Knickerbocker 365 Inc., citing significant violations of federal food safety regulations at its Madison Heights, MI, facility. The letter, dated Sept. 30, 2024, follows an inspection conducted from April 29 through May 31, 2024. The FDA identified issues under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP & PC) rule.

During the inspection, FDA investigators observed several violations that rendered the facility’s ready-to-eat (RTE) breads, rolls, and buns adulterated under the Federal Food, Drug, and Cosmetic Act. At the conclusion of the inspection, the FDA issued a Form 483, Inspectional Observations, to the facility, highlighting the need for corrective action. Knickerbocker 365 Inc. submitted responses in June, but the FDA deemed the proposed actions inadequate.

Key Violations:

1. Failure to Address Recontamination Hazards:
   Knickerbocker’s hazard analysis failed to identify and evaluate recontamination risks with environmental pathogens such as Salmonella. Post-baking steps like cooling, slicing, and packaging were not safeguarded by sanitation preventive controls. Furthermore, the company’s environmental testing procedure was outdated and inconsistently implemented.
2. Inadequate Sanitation Controls:
   Cleaning protocols did not specify sanitizer concentrations or proper cleaning methods for food-contact equipment. Additionally, employees failed to follow environmental monitoring protocols, such as sending swabs for analysis, compromising the facility’s ability to verify sanitation effectiveness.
3. Lack of Supply-Chain Program:
   The company failed to establish and implement a supply-chain program to address ingredient-related pathogen hazards for raw materials like wheat flour and walnuts. Despite claiming that the baking process served as a “kill step,” the facility lacked documentation to verify this process as a preventive control.
4. Inadequate Allergen Control:
   Knickerbocker’s procedures for managing allergens, including wheat, milk, and walnuts, lacked monitoring and verification processes. Shared equipment and insufficient labeling practices posed risks for allergen cross-contact and undeclared allergens on packaging.

The FDA emphasized the severity of these violations, especially given the facility’s history of non-compliance. A previous warning letter was issued in January 2024 for similar failures to declare allergens.

Company Response:

Knickerbocker 365 Inc. pledged to implement additional controls, including employee training and enhanced cleaning protocols, but failed to provide sufficient evidence of corrective action. The FDA will assess these measures during its next inspection.

The full warning letter can be viewed here.

Stew Leonard’s Holdings LLC
Norwalk, CT

Stew Leonard’s Holdings LLC, a Connecticut-based food retailer, received a warning letter from the FDA for serious misbranding violations linked to its Florentine Cookies and Rainbow Cookies. The letter, dated Nov. 18, 2024, followed an inspection at its Danbury, CT facility from Jan. 26 through Feb. 12, 2024. The inspection was prompted by a consumer complaint involving an anaphylactic death linked to the Florentine Cookies, which contained undeclared peanuts and eggs.

The FDA noted that the Florentine Cookies were recalled on Jan. 23, 2024, but the company’s labeling practices failed to meet federal requirements.

Key Violations:

1. Undeclared Major Allergens:
   The Florentine Cookies were misbranded under federal law for failing to declare peanuts and eggs, both classified as major allergens. The Rainbow Cookies similarly lacked allergen declarations for wheat, eggs, and milk.
2. Incomplete Ingredient Listings:
   Both cookie products omitted required ingredient details. For example, the Florentine Cookies label failed to list sub-ingredients like margarine and palm kernel oil, while the Rainbow Cookies omitted several ingredients, including apricot kernels and xanthan gum.
3. Noncompliant Nutrition Facts Label:
   The Rainbow Cookies’ Nutrition Facts label failed to declare added sugars, lacked required vitamin and mineral information, and was improperly formatted.

FDA Comments:

The FDA noted that labeling inconsistencies extended beyond allergen declarations, citing discrepancies in ingredient lists between bulk cookies and final packaging. These lapses pose severe risks to public health, as evidenced by the anaphylactic death.

The full warning letter can be viewed here.

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