FDA WARNING_LETTER - New Manna Food - February 03, 2023

The FDA inspected New Manna Food, a ready-to-eat prepared foods facility in Tamuning, GU, from February 1-3, 2023, identifying serious violations of seafood HACCP (21 CFR Part 123), food labeling (21 CFR Part 101), and facility registration requirements. The firm failed to respond to the issued FDA Form 483. Key HACCP deficiencies include the absence of a written HACCP plan for tuna salad sandwiches to control hazards like histamine, pathogen growth, and undeclared allergens, and inadequate monitoring of sanitation conditions, evidenced by flies in the processing room and potential allergen cross-contact from insufficient cleaning. Additionally, the facility, identified as a qualified facility under 21 CFR Part 117, failed to submit required attestations. The tuna salad sandwich product is misbranded due to multiple labeling violations, including failure to declare major food allergens (wheat, milk, tuna, egg), lack of a common or usual name, missing net quantity of contents, absence of manufacturer/distributor information, and incomplete ingredient declarations. Furthermore, the facility failed to register with FDA as required by Section 415 of the Act. The FDA mandates prompt corrective action within 15 working days, with detailed documentation, to prevent legal action such as seizure, injunction, or registration suspension.