Inspections, Compliance, Enforcement, and Criminal Investigations
Mu Kung Hwa Oriental Foods, LLC 9/15/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
September 15, 2009
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-27
Chung-Youl Han, Co-owner
Hak-Ki Han, Co-owner
Mu Kung Hwa Food Manufacturing Company
121 131st Street South
Tacoma, Washington 98444-4803
Dear Mr. and Ms. Han:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility located at 121 131st Street South,· Tacoma, Washington, on July 1-8, 2009. The inspection was conducted to determine your compliance with FDA's Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Our investigators documented serious deviations from the regulations that cause the products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You may find the Act and associated regulations through links in FDA's Internet home page at http://www.fda.gov.
The deviations include, but are not limited to, the following:
1. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, including washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the workstation, and at any other time when the hands may have become soiled or contaminated, to comply with 21 CFR 110.10(b)(3). However, your employees working in direct contact with food failed to wash and sanitize their hands thoroughly after each absence from the workstation or when their hands may, have become soiled or contaminated. We observed employees entering and exiting the main facility throughout the work shift, between (b)(4) without any of them washing and sanitizing their hands prior to beginning or continuing any stage of production. The only designated hand washing sink in the production facility was unavailable for use since it was used to hold equipment parts (stacked perforated metal sheets and utensils).
2. Your plant and facilities shall be constructed so that drip or condensate from fixtures, ducts and pipes do not contaminate food, food-contact surfaces, or food-packaging materials to comply with 21 CFR 110.20(b)(4). However, the exhaust vent located in the steaming room hood system, directly above the steamers, was observed to be dripping condensate back onto the rice products being prepared in the steamers.
3. You must provide your plant or facility, where necessary, adequate screening or other protection against pests, to comply with 21 CFR 110.20(b)(7). However, you did not provide adequate screening or other protection against pests as evidenced by the following observations:
• An approximately two to three inch gap was present around the exhaust vent of the heater, which exits to the outside through the drop ceiling, in your packaging room. A gap of approximately three feet by six inches was observed as a result of two missing ceiling tiles in the drop ceiling of the packaging room. The sound of a small animal running above the ceiling tiles was heard in the packaging area.
• The south entrance door leading directly into the steaming room from outdoors remained open throughout manufacturing operations.
• The vent to the water heater, which exits to the atmosphere on the east wall of the steaming room, did not have screening.
4. No pests shall be allowed in any area of a food plant and effective measures must be taken to exclude pests, including rodents, from the processing areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). However, you failed to exclude insects and rodents from your processing facility and to protect against the contamination of food on the premises by pests, as evidenced by our observation of not less than 25 dry hard rodent excreta pellets (REPs), each approximately 1/4" in length, on top of plastic bins used to store bulk raw materials (soy beans, sugar, yellow split peas, pearl barley) that were located in the southeast corner of your packaging room. Production equipment (toaster and grinder) used to manufacture ready-to-eat products was located directly adjacent to the plastic storage bins.
5. You must maintain in a sanitary condition, and in repair sufficient to prevent food from becoming adulterated, all buildings, fixtures, and other physical facilities of your plant, and must clean and sanitize utensils and equipment in a manner that protects food, food-contact surfaces, and food-packaging materials from contamination to comply with 21 CFR 110.35(a). However, you failed to do so as evidenced by the following observations:
• An employee working at the large extruder located in the steaming room was observed rinsing extruder parts in the same plastic tub (and water) that was being used to soak and cool fresh, cooked, ready-to-eat rice product.
• Flaking paint was observed along the west wall behind the steamers, within less than five inches from the cooking operations being conducted.
• An employee in the packaging room was observed using the pink colored Slicer (used to cut Duc Bok Yi) without cleaning or sanitizing the machine or food contact surfaces of the machine prior to use. Prior to use by the employee, the machine had product residue from a previous day's production on and around the machine.
• The food-contact surface of an extruder, with a build-up of product residue from a previous day's production, was stored on a shelf located in the packaging room throughout the inspection.
• A wooden handled pastry brush, sitting in a mixture of sesame and vegetable oil, was observed to have residual oil and unknown debris stuck to its handle.
• A cutting board that had been washed with a cloth towel from the cleaning bucket was then rinsed and placed directly on the wet, dirty floor of the steaming room adjacent to the steamers.
• An employee used a bristle-brush, previously observed on the soiled floor of the steaming room, to clean the large extruder in the steaming room.
• Employees in the steaming room were observed washing equipment parts and utensils in large plastic bins that were placed directly on the soiled, wet floor. A cleanser was used in the water; however, the equipment was not sanitized after washing or before use in production.
• The cement floor throughout your processing areas was eroded in places and contained pockets and cracks up to two feet in length by two inches deep, resulting in exposed aggregate and pooling water, and contributing to potential contamination of the food and equipment by up-splash of standing water from the floor.
• The floors, walls and ceiling of the secondary packaging room (outside and to the west of the packaging room) is constructed of plywood or similar wood materials which are porous, absorbent and can not easily be cleaned or sanitized.
6. You must hold or store toxic cleaning compounds, sanitizing agents, and pesticide chemicals in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, to comply with 21 CFR 110.35(b)(2). However, a bottle of Clorox bleach was observed directly adjacent to a rice flour milling machine, located along the east wall of the steaming room.
7. 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, the small extruder in the packaging room was used to cut dough balls for the Combination Rice Cake, which contained walnuts. The same extruder was then used to process a different rice cake product that did not contain walnuts. The equipment was not "torn down" or cleaned and sanitized before preparing the non-walnut containing rice cake product.
8. The plumbing in your facility must be adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils, to comply with 21 CFR 110.37(b)(3). However, hoses without backflow prevention devices were observed lying on the cement floor in dirty water or touching soiled areas, submerged in the large plastic tubs that were being used to wash equipment parts and utensils, submerged in a tote of water used to clean rice, and submerged in water in the large extruder during processing.
9. You must provide adequate and convenient hand washing facilities, with. running water at a suitable temperature, to comply with 21 CFR 110.37(e). However you failed to do so, as evidenced by the following observations:
• The only employee hand washing station, located adjacent to the three compartment sink and the employee restroom, was unavailable for use throughout the production period. The station had equipment parts (stacked perforated metal sheets) and utensils that prevented use.
• There were no hand washing stations available in the packaging room or secondary packaging room.
10. All of your food receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging and storage operations shall be conducted in accordance with adequate sanitation principles and you must take all reasonable precautions to ensure that production procedures do not contribute contamination from any source to comply with 21 CFR 110.80. However, you failed to do so as evidenced by the following observations:
• Your firm began packaging operations in the packaging room while remodeling equipment and materials remained (e.g., unsealed paint cans, a ladder, a paint roller in a paint tray containing fluid paint, tools, electrical cords, a bucket, and rubber gloves). The floors were not cleaned of debris and dust and a strong chemical odor from the paint was still present. Open and partially used bags of raw materials (Le., granulated sugar, blue corn meal, yellow split peas, and green pea flour) were stored directly on the floor of the packaging room prior to and during production operations. Open plastic jars, labeled "GROUND CINNAMON," containing a mixture of sesame and vegetable oil, were observed on the shelf in the packaging room.
• A can of uncapped WD-40 (lubricant containing petroleum distillates) was stored on top of the electrical box-located on the northeast wall of the steaming room, directly above and adjacent to a rice flour milling machine and the rice flour sifting machine. Below the sifting machine, two fresh batches of rice flour were being held in open and exposed tubs/totes.
11. All food manufacturing shall be conducted under the conditions and controls necessary to minimize growth of microorganisms and contamination, including using temperature controls, to comply with 21 CFR 110.80(b)(2). In addition, material scheduled for rework must be identified as such to comply with 21 CFR 110.80(a)(5). However, we observed an uncovered tray of mixed rice dough being stored at ambient temperature in the secondary packaging room underneath the wooden table, on top of a paperboard box. Rice dough, which you identified as "recycle" dough, was being stored uncovered in the cooler; frozen rice cake dough (Sung Phun) was observed being stored partially uncovered in a shipping carton located in the freezer.
This letter is not intended to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that your facility is in compliance with the Act and the Current Good Manufacturing Practice regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Michael J. Donovan, Compliance Officer, at (425) 483-4906.
Charles. M. Breen
Form FDA 483
cc: WSDA with disclosure statement