Inspections, Compliance, Enforcement, and Criminal Investigations
Edenic Soy & Tofu, Inc 7/26/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
- Your plumbing must be of adequate size and design and adequately installed and maintained, to comply with 21 CFR 110.37(b). However, your plumbing is not adequate as evidenced by the following observations.
- There were dead legs connected to the plumbing that supplies water to your ice machine, manufacturing sink, and toilet facility. Dead legs can foster the growth of bacteria, which may include human pathogens, inside the pipes that supply water to your facility. Water from the manufacturing sink is used as an ingredient for your tofu and is used for cooling tofu during manufacturing (21 CFR 110.37(b)(3)).
- There was no air gap or backflow prevention device in the plumbing that supplies water to the cooling tank that sits in front of the sink. Without backflow prevention, contaminated water may be going into your cooling tank (21 CFR 110.37(b)(5)).
- The plumbing on your tofu cooling sink, ice machine, and mop sink drains directly onto the production room floor, as opposed to draining into a sewer or other waste water disposal system. This practice results in a wet production room floor, which can foster the growth and spread of human pathogens, especially Listeria monocytogenes (21 CFR 110.37(b)(2)).
- There was standing water and organic material on the floor of the production room where employees were walking, demonstrating a lack of adequate floor drainage (21 CFR 110.37(b)(4)).
- Your employees must wash their hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, to comply with 21 CFR 110.10(b)(3). However, on 2/1/2011 an employee touched the production room floor while cleaning up organic matter from under the grinding machine. The same employee then dipped his hand in the cooling sink water that was holding tofu for cooling without washing and sanitizing his hands between tasks.
- You must maintain gloves, if they are used in food handling, in an intact, clean, and sanitary condition, to comply with 21 CFR 110.10(b)(5). However, an employee opened the walk-in cooler, moved a wooden pallet, and opened a box of spice mix while wearing green rubber gloves. The same employee then dumped the spice mix into a mixing bowl, added water and immersed his gloved hand into the bowl to mix spices into the water without cleansing and sanitizing the gloves between tasks. The mixture was then poured directly into a batch of ready to eat tofu mix. In addition, another employee picked up a block of tofu with his gloves after rinsing them with water from the nozzle of a hose that had been on the production room floor.
- You must take effective measures to protect against the inclusion of metal in food, to comply with 21 CFR 110.80(b)(8). However, your firm used a frayed and torn metal screen during the tofu pressing operation, where it came in direct contact with tofu liquid and tofu This practice may lead to contamination of your product with metal fragments.
- You must construct, handle, and maintain equipment, containers and utensils used to convey, hold, and store raw material, work-in-process, rework, or food in a manner that protects against contamination, to comply with 21 CFR 110.80(b)(7). However, white buckets that are used to hold finished bulk tofu were stored upside down in direct contact with a dirty wooden shelf and direct food contact storage bins were stored upside down in direct contact with the production room floor.
- All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food, to comply with 21 CFR 110.35(d). However your food-contact surfaces were not adequately cleaned as evidenced by:
- A black mold-like substance on the packaging machine used to convey tofu.
- A chain caked with organic matter and a black mold like substance that was touching in-process tofu.
- Your equipment and utensils must be of such material and workmanship as to be adequately cleanable and must be properly maintained, to comply with 21 CFR 110.40(a). However, you used a wooden stirring utensil that was shredded. Wood, and particularly rough wood, cannot be adequately cleaned because bacteria tend to collect in any rough spot or porous surface. Moreover, use of a shredded stirring utensil risks contaminating food with foreign material. In addition, the interior of the “funnel” piece of equipment that dispenses soy drink has a rough welded surface which cannot be adequately cleaned.
- You must properly store equipment and cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, to comply with 21 CFR 110.20(a)(1). However, there were vines growing along the east outer wall that could constitute a harborage for pests.
- Your employees must wear hair nets, beard covers, and hair restraints, where appropriate, in an effective manner, to comply with 21 CFR 110.10(b)(6). However, on 2/1/2011, while manufacturing ready to eat tofu, three employees were not wearing hair nets or any other form of hair restraint. In addition, one employee with facial hair was not wearing a beard cover.
- Yourplant must be constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair, to comply with 21 CFR 110.20(b)(4). However, the wall of your production room where tofu and soy drinks are manufactured had extensive shredded paint within a foot from where tofu products are manufactured. In addition, your production room floor was cracked exposing the concrete aggregate, which is a porous surface that can serve as a reservoir for pathogens.