This is an easy one svelasan, condensate is an obvious microbial risk for both USDA and FDA.
The "explicit citation" is here: 21 CFR 110.20(b)(4
(4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.
Examples of actual enforcement actions taken because of condensate can be found by googling "warning letter condensate above".
Condensate was observed dripping from the ceiling directly above the hand wash sink in the packaging room during the packaging of mung bean and soybean sprouts and dripping from the ceiling in front of the main door leading into the mung bean growing room. Condensate may foster the growth, contribute to the spread, and/or allow for the development of harborage sites for pathogens, such as Listeria monocytogenes.
Condensation was dripping from walls and/or ceilings in the Seed Receiving Room, Seed Storage Room, Mung Bean Processing Area, and especially in your green sprout operation where sprouts were stored directly under pipes with condensation build-up. Further, water was pooling on the floor and mold was accumulating in the Seed Receiving Room. Condensate and standing water may foster the growth of and contribute to the spread of pathogens, for example, Listeria monocytogenes. Condensate dripping onto product may contaminate product directly and/or contaminate equipment or personnel, which can serve as routes of contamination.
Your plant and facility must be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts, and pipes does not does not contaminate food, food contact surfaces, or food packaging materials, to comply with 21 CFR 110.20(b)(4). However, piping approximately four feet above a conveyer transferring ready to eat product from the cooler to packaging line (b)(4), appeared to have condensate and water stains on the underside of the piping directly above the product.
Your firm failed to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2). Specifically, we observed:
- On February 10, 2016, you were mixing ready to eat pesto pasta directly under an area in the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
- On February 16, 2016, you were storing an uncovered rack of ready to eat mushroom quesadilla in the same area of the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
- On February 10, 2016, your employee transported uncovered ready to eat vegetables through a doorway, from the Veg Prep Room into the Prepared Veg Cooler. A significant amount of condensate had formed above the doorway and was dripping onto the surface below.
- On February 10, 2016, your employee was cutting chives and beets on a work surface directly underneath a leaking condensate drainage pipe in the Veg Prep Room.
- On February 16, 2016, you were holding uncovered ready to eat egg salad in large white barrels that were placed in an area below the condenser. Condensate was observed to be dripping at a rate of approximately once per second from the condenser fan bolts in the K8/K9 Room.
- On February 16, 2016, your employee transported uncovered ready to eat couscous through an area in the K8/K9 Room where condensate was dripping from an area around the condenser fan bolts at a rate of approximately once per second.
Your firm failed to ensure the plant and facilities are constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food contact surfaces, or food-packaging materials, as required by 21 CFR 110.20(b)(4). Specifically, condensate was observed on the processing room ceiling directly above the IQF (b)(4) which conveys blanched, diced onions and on a water line located above the main transport area in the processing room where rework product is transported (b)(4) to the blancher. Condensate may foster the growth, contribute to the spread, and/or allow for the development of harborage sites for pathogens, such as L. monocytogenes.
Your firm’s response indicates that you will (b)(4) directly over food contact areas. However, your response provides no details concerning how you will (b)(4) and how you will assess whether this correction and the (b)(4) are effective in minimizing the condensation above food and food contact surfaces. Your response does not address how to you will prevent future recurrence of this violation, such as through increased monitoring and assessment.
In addition, our investigator observed actively dripping condensate on an overhead chilled water flume a long the west wall in the Kettle Cook Room (formerly the Hot Fill Room). Directly below this flume was a clean food contact storage shelf with clean food contact equipment parts, a stainless-steel food contact table, a lightening mixer used to mix totes (b)(4) of product, and a white paddle and rake which are also food contact surfaces. These pieces of equipment were actively being used in products (e.g. Macaroni and Cheese) within the room during our inspection. Your firm was manufacturing both USDA and FDA regulated products in this room at the time of the inspection.
• Further, our investigator observed in the Kettle Cook Room (formerly the Hot Fill Room), condensation forming directly above an open kettle identified as a liquefier, in the northeast corner of the room. Our investigator observed the employees manufacturing product for approximately 15 to 25 minutes and never saw the lid closed. The liquefier/kettle was actively being used and had product (Creamy Broccoli Chicken dinner, a USDA product) in it. The Kettle Room (formerly the Hot Fill Room) is full of steam and contains copious amounts of water. During the inspection, your firm was manufacturing a USDA product in this kettle. However, your firm 's Bake Side Plant Manager informed our investigator that the process is the same for FDA (i.e. margarine and cream) and USDA products.
• Water was seen pooling on top of a (b)(4) cart in the Work in Process Cooler (WIP) (formerly the Holding Cooler). These (b)(4) carts are used for moving ingredients (i.e. margarine) and finished products (i.e. Creamy Broccoli Chicken dinner, a USDA product and others) around the facility.
• Additionally, our investigator observed condensation and dripping from ingredient flumes in the mixing room which could potentially drip condensate into uncovered (b)(4) or onto the utensils hanging along the walls. All ready-to-eat salads go to the mixing room (i.e. Cheesy Macaroni Salad and various potato salads).