One Roof LLC – FDA Warning Letter, Dec 9, 2024

The FDA inspected Atwater’s ready-to-eat food manufacturing facility in Baltimore, MD, from October 24, 2024, to December 9, 2024, following a voluntary recall of Spider Web Tarts due to undeclared almond. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117) and labeling regulations (21 CFR Part 101). Consequently, Dark Chocolate Walnut Cookies and Spider Web Tarts were deemed adulterated and misbranded.

Key violations include the failure to conduct a hazard analysis for specific products, and to identify and evaluate allergens, environmental pathogens, mycotoxins, and metal as hazards requiring preventive controls. The firm also failed to adequately clean and sanitize equipment, with observed low sanitizer concentration and improper employee hygiene. Environmental monitoring records showed presumptive positive Listeria spp. findings, and non-pathogenic Listeria innocua was isolated from facility swabs, indicating conditions suitable for pathogen growth. Misbranding violations included incorrect or missing nutrition information, failure to declare all ingredients by common name, and inaccurate net quantity of contents on product labels.

The firm provided a response on December 24, 2024, outlining corrective actions such as creating hazard analyses, implementing training, checklists, and new logs, repairing equipment, and gathering supplier documentation. Misbranding issues for seasonal products are planned for correction by Fall 2025. The FDA will verify the adequacy of these actions during future inspections. Failure to fully address these violations may result in legal action, including seizure and injunction. A written response detailing corrective steps is required within 15 working days.