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FDA Warns Noodle Manufacturing Plant of Unsanitary Conditions
The agency sent a warning letter based on an internal inspection and investigation.
3 Min Read
The factory conditions included mold on ceilings and floors, as well as worker hygiene issues.Image courtesy of Oliver Strewe / The Image Bank via Getty Images
The US Food and Drug Administration sent a warning letter to Wan-Gee Foods Inc. of St. Louis, MO, stemming from an internal investigation and subsequent investigation.
The inspection covered the manufacturer's not ready-to-eat (nRTE) noodle products manufacturing operation. FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117).
Based on its inspectional findings, FDA found the nRTE noodle products (wonton wrappers, egg roll wrappers, and noodles) processed in the facility are adulterated by being prepared, packed, or held under insanitary conditions and might have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited, the agency stated.
At the conclusion of the inspection, the FDA investigators issued a letter (FDA form 483) covering inspection observations. To date, Wan-Gee Foods hasn't responded to the inspection.
The Hazard Analysis and Risk-Based Preventive Controls list includes, but is not limited to:
Company did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your nRTE noodles products.
Company did not identify and evaluate the hazard of bacterial growth and/or toxin formation due to lack of time/temperature control as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for your noodle products during production. This includes identifying and evaluating the hazard of mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control for your noodle products.
Company did not implement your preventive controls procedures to significantly minimize or prevent contamination with the hazard of metal in your nRTE noodle products as required.
Company's written allergen preventive control does not include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label for your nRTE noodle products, as required.
Company did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food as required. This includes apparent black mold formed on the ceiling directly over a drying canton noodle product in several locations throughout the room. The apparent mold covered approximately 30% of the ceiling. The fans used to blow heated air directly onto the product to dry it were covered in approximately ¼ inch of apparent filth. In addition, the concrete floor along the walls in multiple locations throughout the drying room had what appeared to be white and greenish-colored mold. The walls had apparent black mold in several different locations throughout the drying room.
Company did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect again contamination of food, as required.
Wan-Gee Foods Inc. has 15 days to respond to FDA in writing of the specific steps it has taken to correct violations, with an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
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