- Q.C. instrument accuracy, maintenance
Instruments used for measuring and recording conditions that control or prevent the growth of undesirable microorganisms are not adequately maintained. December 9, 2015, Observations Include Specifically, the thermal study that was completed by the process control authority specified a minimum time and temperature requirement for the destruction of harmful microorganisms. The recorder and other instrumentation that the firm has in place to monitor and record those times and temperatures are not functioning properly at the time of inspection. December 23, 2015, Observations Include Specifically, improvements have been made where some of the time and temperature data recorded in the thermal kill step can now be viewed in an Excel spreadsheet by removing the chip and uploading the information into an Excel document, but the information is very difficult to decipher and understand. The machine has the capability to generate a chart/graph record in real-time but lacks the proper recording pen for doing so. The Owner/Manager has committed to finding the appropriate recording pen and using the printed chart/graph for the official record.
- Drip and condensate
The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food contact surfaces and food-packaging materials. December 9, 2015 Observations Include Specifically, condensate drip was observed throughout the warehouse ceiling/roof area where product packaging is stored. Additionally, water was observed dripping from the seams of ribbed steel overhead the open tanks that are used to hydrate soybeans. December 23, 2015 Observations Include Specifically, a condensate problem still exists throughout the ceiling/interior roof area of the warehouse. The owner/managers have requested to have until May 1st, 2016, to have repairs made throughout the warehouse that includes roof repair where needed, insulation added to help in controlling condensate and a ceiling installed for protecting food and packaging materials from any and all overhead contamination.
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12/23/2015 | Pre Opening |
- Drip and condensate
The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces and food-packaging materials. Specifically, condensate drip was observed throughout the warehouse ceiling/roof area where product packaging is stored. Additionally, water was observed dripping from the seams of ribbed steel overhead the open tanks that are used to hydrate soybeans.
- Teardown equipment/thorough cleaning
Failure to take apart equipment as necessary to ensure thorough cleaning. Specifically, a significant portion of the food contact surfaces are not designed to clean in place (i.e. soy grinders, soymilk drainers, valves, dead-end pipe and upper levels of soymilk vessels) and therefore must be manually cleaned and sanitized, but were not. A representative from the detergent company was onsite and committed his services to create a sanitation procedure that will identify equipment that requires manual cleaning and sanitizing, and specifications for carrying out effective cleaning procedures.
- Q.C. instrument accuracy, maintenance
Instruments used for measuring and recording conditions that control or prevent the growth of undesirable microorganisms are not adequately maintained. Specifically, the thermal study that was completed by the process control authority specified a minimum time and temperature requirement for the destruction of harmful microorganisms. The recorder and other instrumentation that the firm has in place to monitor and record those times and temperatures are not functioning properly at the time of inspection.
- Lack of effective pest exclusion
Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests. Specifically, apparent droppings that resemble mouse feces was observed near the soybean storage area of the warehouse and on the exterior of two soybean super-sacks.
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12/09/2015 | Pre Opening |
- Seams on food contact surfaces
Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles, dirt and/or organic matter and the opportunity for growth of microorganisms. Specifically, we observed many discolored and rough welds in the product zone of equipment throughout the processing plant. For example: the soaking tanks and discharge ramp, the inside of the vacuum chamber above the milling machine as seen through the sight-glass, milling machine hopper, soy milk tanks, pipes, fittings and valve installations throughout the production area. August 3rd Pre-Opening Inspection: In addition to the above list of areas where rough and discolored welds are identified and still present, additional areas of open seams were identified along the edges of screen that makes up the De-Watered Sifter and all around screens used in the soy milk filtration tanks on the upper deck just prior to the heat exchanger. Also discussed is the need to replace pipe gaskets, in addition to other worn and brittle rubber parts throughout the processing equipment. October 22 Pre-Opening Inspection: A food grade sealant was applied along the edge of screening used in the De-Water Sifter unit in an effort to seal the seam and improve cleaning. However, the rods that are used for sliding screens into place inside the soybean hydration tanks were found to be hollow and must be solid material or sealed in a manner that will not allow juice from the hydrated beans to enter the interior of the rod, for proper cleaning. Additionally, it was determined that a coating had been applied to the stones of the soybean grinder. That coating must be identified as safe for food contact surfaces, or removed.
- Reasonable precautions
All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, I observed a large quantity of apparent rust flakes covering an overhead beam in the filler room between the two fillers and above the work table. October 22 Pre-Opening Inspection: The drainage channel that conveys hydrated soybeans from the hydration tanks to the De-Water Sifter is directly underneath the hydration tank platform and is exposed to potential contamination from above such as drip. Additionally, the filler bowl underneath the tank platform on the "Firm Tofu" line is not covered and is exposed to potential drip. There was also a heavy dust accumulation observed on the overhead beam above the open-top soymilk storage tanks on the "Firm Tofu" line. A letter of guarantee is needed from the manufacturer of the cloth that is used to line the pans on the "Firm Tofu" line that verifies the material is safe and made of food grade material.
- Water quality -- wash, rinse, convey food
Water used to convey food is not safe and/or of adequate sanitary quality. Specifically, the water used in the cold water tunnel of the finished product is not treated with a residual sanitizer for the control of microorganisms. October 22 Pre-Opening Inspection: The firm is said to be working with Iowa State University to develop a water treatment regimen that will ensure proper water quality in the packaged Tofu cooling tank. ISU is also said to be conducting a thermal study to asses the effectiveness of the proposed kill step for Salmonella enterica, Listeria monocytogenes and spoilage bacteria.
- Labeling
The finished product label that was available during this inspection was not the final draft and was missing the list of ingredients and the net contents in both standard and metric measurements. August 3rd Pre-Opening Inspection: Labels were not reviewed or discussed. October 22 Pre-Opening Inspection: Firm is said to be working with Iowa State University for a full label review.
- Failure to clean - general
Failure to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food. Specifically, we observed apparent product residue in the boil kettle tanks, in addition to the vacuum chamber above the milling machine and the milling machine itself. Additionally, a foul odor was detected coming from the discharge line of the plate cooler upon startup. Much of the equipment is not designed to clean in place and was not manually cleaned at the end of production. Examples include the soaking tanks and all contact surfaces between soaking tanks and the vacuum chamber, the vacuum chamber above the milling machine, the milling machine itself, pulping machines, soy milk tanks, lines, valves, fillers, etc. August 3rd Pre-Opening Inspection: Although it appears that improvements have been made related to the cleaning of equipment and utensils, much of the equipment is still not able to be circulated for effective cleaning and sanitizing of pipe, valves, screens, plate heat exchanger and all hard to reach areas of food contact areas. Observed soiled pulping machines and soy milk tanks on the upper deck just before the heat exchanger. October 22 Pre-Opening Inspection: Equipment appeared to be clean, all pipe gaskets were said to have been replaced and screens in the three soymilk separation units are new. The thin-wall plate heat exchanger on the upper deck was disassembled and found to be clean with like-new plate-gaskets, and the product burn-on had been removed from the boil kettle tanks. The firm is working with a chemical company to create cleaning procedures that are said to include Clean In Place (CIP) procedures for enclosed equipment, and written procedures for manually cleaning equipment. A chemical representative joined us during the inspection to identify food contact surfaces from the soybean hydration tanks forward through the process
- Testing
Failure to perform microbial testing where necessary to identify sanitation failures and/or possible food contamination. Specifically, at the time of this pre-opening inspection, the applicant has not consulted a process authority or accredited laboratory for a shelf-life study or any type of microbiological testing on the finished product to ascertain food safety. August 3rd Pre-Opening Inspection: Firm is said to be in consultation with an outside laboratory to perform quality control testing, in addition to ISU for process control guidance. October 22 Pre-Opening Inspection: Firm is said to be working with Iowa State University for process controls, microbial testing and shelf-life study.
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10/22/2015 | Pre Opening |
- As source of contamination
Plumbing constitutes a source of contamination to water supplies. Specifically, a potable water line was observed plumbed directly into the wet bean vacuum chamber above the milling machine with no back-flow protection that effectively protects the potable water line from contamination from the contents of the wet bean vacuum chamber. Additionally, there were potable water lines that were observed plumbed directly into the hot and cold bath tanks, below the flood level of each tank, that must also be protected from back-flow.
- Seams on food contact surfaces
Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles, dirt and/or organic matter and the opportunity for growth of microorganisms. Specifically, we observed many discolored and rough welds in the product zone of equipment throughout the processing plant. For example: the soaking tanks and discharge ramp, the inside of the vacuum chamber above the milling machine as seen through the sight-glass, milling machine hopper, soy milk tanks, pipes, fittings and valve installations throughout the production area, etc. August 3rd Pre-Opening Inspection: In addition to the above list of areas where rough and discolored welds are identified and still present, additional areas of open seams were identified along the edges of screen that makes up the De-Watered Sifter and all around screens used in the soy milk filtration tanks on the upper deck just prior to the heat exchanger. Also discussed is the need to replace pipe gaskets, in addition to other worn and brittle rubber parts throughout the processing equipment.
- Testing
Failure to perform microbial testing where necessary to identify sanitation failures and/or possible food contamination. Specifically, at the time of this pre-opening inspection, the applicant has not consulted a process authority or accredited laboratory for a shelf-life study or any type of microbiological testing on the finished product to ascertain food safety. August 3rd Pre-Opening Inspection: Firm is said to be in consultation with an outside laboratory to perform quality control testing, in addition to ISU for process control guidance.
- Precluding contaminants
The design / construction / use of equipment and utensils fails to preclude the adulteration of food with metal fragments. Specifically, I observed metal shavings and fragments of metal throughout the processing equipment that is believed to have originated from grinding rough welds in the product zone.
- Suitable locations
Failure to provide hand washing facilities at each location in the plant where needed. Specifically, the only handwash station is located near the main entry door into the processing room and is not convenient for use in the filler room or in the area of processing beans and soy milk where hands are frequently contaminated. August 3rd Pre-Opening Inspection: A self-contained foot pump operated hand wash sink was placed in a convenient location of the processing plant, but a handwash sink that is properly plumbed with hot and cold running water that is plumbed to drain and supplied with soap and single use hand drying towels is needed in a location that is convenient for frequent use by operators in the filler room, in addition to the soy milk processing area.
- Labeling
The finished product label that was available during this inspection was not the final draft and was missing the list of ingredients and the net contents in both standard and metric measurements. August 3rd Pre-Opening Inspection: Labels were not reviewed or discussed.
- Failure to clean - general
Failure to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food. Specifically, we observed apparent product residue in the boil kettle tanks, in addition to the vacuum chamber above the milling machine and the milling machine itself. Additionally, a foul odor was detected coming from the discharge line of the plate cooler upon startup. Much of the equipment is not designed to clean in place and was not manually cleaned at the end of production. Examples include the soaking tanks and all contact surfaces between soaking tanks and the vacuum chamber, the vacuum chamber above the milling machine, the milling machine itself, pulping machines, soy milk tanks, lines, valves, fillers, etc. August 3rd Pre-Opening Inspection: Although it appears that improvements have been made related to the cleaning of equipment and utensils, much of the equipment is still not able to be circulated for effective cleaning and sanitizing of pipe, valves, screens, plate heat exchanger and all hard to reach areas of food contact areas. Observed soiled pulping machines and soy milk tanks on the upper deck just before the heat exchanger.
- Food-contact - corrosion resistant
Lack of corrosion-resistant food contact surfaces. Specifically, I observed several bolts and/or connectors in the soaker tanks, and down-stream from the soaker tanks, that appear to be rusty and corroded.
- Water quality -- wash, rinse, convey food
Water used to convey food is not safe and/or of adequate sanitary quality. Specifically, the water used in the cold water tunnel of the finished product is not treated with a residual sanitizer for the control of microorganisms.
- Reasonable precautions
All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, I observed a large quantity of apparent rust flakes covering an overhead beam in the filler room in between the two fillers and above the work table.
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08/03/2015 | Pre Opening |
- Safe and adequate sanitary quality
Failure to use water which is safe and of adequate sanitary quality in food and on food-contact surfaces. Specifically, we observed that the water that is used for soaking the raw soybeans is supplied by a copper line that is plumbed into the discharge manifold of the boil kettle tanks, which are used for cooking the raw soy milk
- Food-contact - corrosion resistant
Lack of corrosion-resistant food contact surfaces. Specifically, we observed a soldered copper line directly connected to the stainless steel discharge manifold of the boil kettle tanks used for cooking soy milk. Additionally, the writing observed on the black water hose and food transfer hose is in Chinese and needs a letter of guarantee from the supplier stating that the material is safe for use in food processing.
- Shown to be effective
The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment. Specifically, as stated, visual indications and foul odors not associated with soybean processing were observed and detected throughout the equipment used for processing.
- Failure to clean - general
Failure to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food. Specifically, we observed apparent product residue in the boil kettle tanks, in addition to the vacuum chamber above the milling machine and the milling machine itself. Additionally, a foul odor was detected coming from the discharge line of the plate cooler upon startup. Much of the equipment is not designed to clean in place and was not manually cleaned at the end of production. Examples include the soaking tanks and all contact surfaces between soaking tanks and the vacuum chamber, the vacuum chamber above the milling machine, the milling machine itself, pulping machines, soy milk tanks, lines, valves, fillers, etc.
- Suitable locations
Failure to provide hand washing facilities at each location in the plant where needed. Specifically, the only handwash station is located near the main entry door into the processing room and is not convenient for use in the filler room or in the area of processing beans and soy milk where hands are frequently contaminated.
- Drainage
Lack of adequate drainage of areas which may contribute to contamination of food by foot-borne filth. Specifically, We observed pooled standing water on the floor throughout the food processing areas.
- Drip and condensate
The plant is not constructed in such a manner as to prevent drip and/or condensate from contaminating food, food-contact surfaces and/or food-packaging materials. Specifically, we observed overhead drip from the ceiling area above and in close proximity to the fillers.
- Sufficient space
Failure to provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food. Specifically, we observed the ingredient warehouse tightly packed from wall to wall with pallets of ingredients, equipment, labels and other crates of unknown contents.
- Labeling
The finished product label that was available during this inspection was not the final draft and was missing the list of ingredients and the net contents in both standard and metric measurements. All ingredients observed were imported from China and all labeling was written in Chinese and therefore there must be an Invoice and letter of guarantee from the supplier that describes in English what the product is, directions for use and a list of ingredients that would then be carried over onto the ingredient statement of the finished product.
- Testing
Failure to perform microbial testing where necessary to identify sanitation failures and/or possible food contamination. Specifically, at the time of this pre-opening inspection, the applicant has not consulted a process authority or accredited laboratory for a shelf-life study or any type of microbiological testing on the finished product to ascertain food safety.
- Water quality -- wash, rinse, convey food
Water used to convey food is not safe and/or of adequate sanitary quality. Specifically, the water used in the cold water tunnel of the finished product is not treated with a residual sanitizer for the control of microorganisms.
- Lack of effective pest exclusion
Effective measures are not being taken to exclude pests from the processing areas and/or protect against the contamination of food on the premises by pests. Specifically, the plant does not have a pest control program in place at the time of inspection.
- Materials and workmanship
The design, materials and workmanship of equipment and utensils does not allow proper cleaning and maintenance. Specifically, we observed a garden rake that is used for handling wet soybeans at the soaking tanks that is not cleanable, the two vacuum chambers (one above the soaking tanks and one above the milling machines) do not allow for effective cleaning, maintenance and inspection. The soybean ramp that is used to drain the beans out of the soaker tanks and deliver them to the sifter was retrofitted with a false bottom that covers other drainage ports that were observed full of stagnant water. The diverter plate in the hopper of the milling machine does not allow for effective cleaning and sanitizing. The pipe and valves that make up the discharge manifold for the boil kettle tanks has the ability to create several large areas of dead-end pipe where product and/or water can stagnate. The potable water line supplying the plate cooler can not be removed to allow for the plate cooler to be disassembled.
- Seams on food contact surfaces
Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles, dirt and/or organic matter and the opportunity for growth of microorganisms. Specifically, we observed many discolored and rough welds in the product zone of equipment throughout the processing plant. For example: the soaking tanks and discharge ramp, the inside of the vacuum chamber above the milling machine as seen through the sight-glass, milling machine hopper, soy milk tanks, pipes, fittings and valve installations throughout the production area, etc.
- Metal / extraneous materials
Failure to take effective measures to protect against the inclusion of metal and other extraneous material in food. Specifically, we observed metal fragments along the edge of a cut-out for an exhaust fan above the boil kettle tanks, and foam isolation covering pipe above same tanks. Additionally, we observed sticker decals located on stainless steel pipe that is within the product zone and capable of falling into product or vessels.
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07/06/2015 | Pre Opening |
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