Hazard Analysis and Preventive Controls
- Did not identify Staphylococcus aureus as a hazard of concern which can be an issue if noodle dough is temperature abused.
- "Did not identify and evaluate the hazard of bacterial growth and/or toxin formation {of Staphylococcus aureus] due to lack of time/temperature control as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for your canton noodles during finished product storage. The canton noodles are treated as shelf stable, stored at ambient temperatures, and are not labeled to be kept refrigerated or frozen. You do not know the water activity of the finished product canton noodles, including whether it is above 0.85."
- "did not identify and evaluate the hazard of mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control for your noodle products. The noodles contain wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard to be considered for these products."
- "did not implement your preventive controls procedures to significantly minimize or prevent contamination with the hazard of metal in your nRTE noodle products. Our investigators observed damage and missing pieces to your metal cutting blades used to shorten the dried noodles after the drying room step. The investigators requested monitoring records associated with the metal detector, but you did not provide them during the inspection."
- "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" "procedure does not ensure all finished product labels declare all allergens present in the finished food to ensure finished food is not misbranded under section 403(w) of the Act (21 CFR 117.135(c)(2) because you do not document your review of finished product labels to ensure all allergens are properly declared."
- "do not maintain any monitoring or corrective action records of your review of your product labels to ensure the allergen ingredients are listed on the label for each batch produced. The only record you maintain for production is your mixing log and it does not include are view of the allergen ingredients in the finished food against the packaging label."
- Black mold - "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 percent of the ceiling. Further, the fans used to blow heated air ((b)(4) degrees Fahrenheit) 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."
- Product on floor - "Employee hanging noodles on racks (b)(4). During our inspection, our investigators observed the two bins separate, causing an approximate 2-to-3-in. gap in between. This resulted in the bottom quarter of the noodles coming into contact with the floor."
- Condensation - "heavily beaded condensation formed over and falling onto boxed wonton wrappers, lot number 05021168, in the blast storage freezer. Our investigators also observed condensation falling onto packaged finished product. Although the product is wrapped in wax paper, the packaging is made of thin cardboard that is not sealed and the product is susceptible to contamination while it is held overnight in the blast freezer. Our investigators observed ice formed in several other locations in the freezer, including the floor, freezer units, and walls."
- Facility issues / potential foreign objects - "brittle plastic in several areas on the tray was broken and/or frayed. (b)(4) trays being used in production were in similar condition.. Foam was present on the underside of the (b)(4) that comes indirect contact with the top layer of the wrappers during cutting. The foam is porous and not easily cleanable. Our investigators observed deteriorating foam on (b)(4) blade presses ((b)(4) egg roll and (b)(4) wonton), and parts of the foam were missing in several areas around the edges."
- Personal hygiene issues - 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 by 21 CFR 117.10(b). Specifically, on May 2, 2023, five out of ten employees were observed in street clothes covered in apparent filth while handling dough used to manufacture wonton wrappers
MARCS-CMS 660360 — NOVEMBER 09, 2023
Recipient:
Samson Wang
CEO/President
Wan-Gee Foods, Inc.
10849 Midwest Industrial Blvd.
St. Louis, MO 63132
United States