FDA 483 - Tawa Services Inc. - June 05, 2025

An FDA inspection conducted from May 20 to June 5, 2025, at a ready-to-eat food manufacturer in Buena Park, CA, identified significant deficiencies in its food safety practices. The observations, documented on an FDA Form 483, indicate critical areas requiring immediate attention to ensure compliance with federal food safety regulations, particularly those related to preventive controls.

The primary issues centered on the firm's hazard analysis, which failed to identify crucial hazards like lead and mycotoxins in imported ingredients and did not adequately address bacterial growth risks from insufficient time and temperature controls during product processing and cooling. Furthermore, the company was not effectively implementing its sanitation preventive controls for FDA-regulated products. Inspectors observed instances of product splashing, the use of uncleaned thermometers for product temperature monitoring, and inadequate protection of products during internal transport, all posing contamination risks.

Additionally, the inspection revealed shortcomings in allergen preventive controls. The firm's label monitoring during packaging was inconsistent with its own food safety plan, and historical records for allergen verification were missing. The current allergen verification process lacked a critical comparison against a master label or ingredient statement, potentially leading to undeclared allergens. The manufacturer is expected to review these observations and implement comprehensive corrective actions to address these serious food safety and quality control concerns.