November 1, 2013
Confirmed Delivery via United Parcel Service
Ref. - 2014-01
Michael J. Harding, General Manager
Reser's Fine Foods, Inc.
3167 SE 10th St.
Topeka, KS 66607-2508
Dear Mr. Harding:
The U.S. Food and Drug Administration (FDA) conducted an inspection at your ready-to-eat salad manufacturing facility, Reser's Fine Foods, Inc., 3167 SE 10th St., Salad Plant, Topeka, Kansas 66607-2508, between October 8 and 29, 2013. During our inspection, FDA investigators collected environmental samples from multiple areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes
), a human pathogen. In addition, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulations, Title 21 Code of Federal Regulations, Part 110 (21 CFR Part 110). These CGMP violations and our findings of L. monocytogenes in your processing facility cause your ready-to-eat salad products to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to severe, sometimes life-threatening illness called listeriosis, an atypical food borne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
FDA laboratory analysis of sample INV791987, collected on October 9, 2013, confirmed two environmental swabs were positive for L. monocytogenes. FDA collected these positive swabs in the "Mayo Room" from the exterior of a metal water line observed to have condensate dripping into a mayonnaise mixing vat (sub 1), a location which provides a direct route of contamination into food; and from the control touch screen for the mayonnaise mixing vat (sub 4). The presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food.
We acknowledge your firm conducted voluntary recalls in the United States and Canada as a result of findings by the Canadian Food Inspection Agency of L. monocytogenes in finished products manufactured in your facility on September 5 & 18, 2013, and FDA's environmental sample results.
FDA investigators also observed the following CGMP violations:
1. You failed to clean and sanitize food-contact surfaces in wet-processing before use, to preclude contamination with microorganisms, as required by 21 CFR 110.35(d)(2). Specifically, our investigators witnessed your firm's between-lot cleaning and sanitizing of filling lines (b)(4) and (b)(4) which are used to fill products such as Cheesy Macaroni Salad, Potato Salads, and other ready-to-eat salads. During this process, your employees were observed spraying down the lines with potable water and sanitizing the lines with what was reported to be (b)(4). This process appeared to have been completed according to your firm's procedure entitled, "Changeover Procedures". The directions for use for (b)(4) state, "Prior to application, remove gross food particles and soil by a pre-flush, pre-scrape or when necessary, a pre-soak. Then thoroughly wash or flush objects with a good detergent or compatible cleaner followed by a potable water rinse before application of the sanitizing solution." Use of a detergent prior to sanitization was not observed and according to the plant manager, does not occur until the complete cleaning (b)(4). Additionally, your procedure does not direct personnel to use a detergent prior to sanitization.
2. Your plant is not constructed in such a manner as to prevent drip and condensate from contaminating food and food-contact surfaces, as required by 21 CFR 110.20(b)(4).
• Our investigator observed condensation, a long with what appeared to be mold, directly over the open macaroni hopper in the Potato Cook Room (formerly the Cook Room) that was in use during this inspection. This macaroni is used in USDA and FDA regulated product, like Macaroni and Cheese.
• 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).
3. You failed to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination, as required by 21 CFR 110.35(e).
Specifically, our investigators observed the following:
• A white food contact paddle used in products like Macaroni and Cheese stored upside-down resting against the railing on the upper platform in the Potato Room.
• A white food contact shovel which could be used in products like Macaroni and Cheese stored between an "I" beam and the metal wall resting on the concrete shelf in the Curwood Pack Off Area, along the north interior wall.
• A white shovel used in products like Macaroni and Cheese balancing precariously on a metal bar in the Potato Room that could easily fall for any number of reasons. This was along the east wall.
• An orange cord used to hold plastic wrap around the top of the totes called (b)(4), was found hanging into standing water in the Work-In-Process (WIP) Cooler (formerly the Holding Cooler). Your (b)(4) are used for all finished products on the Bake Side.
• Additionally, our investigator observed a metal "barrel hoist" in the mixing room which was used to lift barrels of ingredients and pour them into the mixing hoppers sitting on the floor in standing water. When this apparatus is used, there is no mechanism to prevent water from running down the length of the hoist and into the hopper. This was demonstrated by your firm on mixer (b)(4). Our investigator and accompanying inspectors from the State of Kansas witnessed floor water drain into the hopper off of the barrel. All ready-to-eat salads go to the mixing room (i.e. Cheesy Macaroni Salad and various potato salads).
4. Your plant is not constructed in such a manner as to allow floors and ceilings to be adequately cleaned and kept clean and kept in good repair per 21 CFR 110.20(b)(4). Specifically, our investigator observed, along the south side of the Curwood Baking Room (formerly known as the Production Floor), an old unused pit scale over which had been epoxied. This pit scale was approximately 1 1/2 feet by 1 1/2 feet in size with obvious cracks around all four sides. When an employee steps on or rolls equipment over the epoxied hard surface, water comes out of the cracks along all four sides. This water would be in contact with the bottom of employee shoes, (b)(4) cart wheels or other equipment, such as fork-lifts, in the facility. This room is used to manufacture products like Macaroni and Cheese. Any contamination could be transferred throughout the facility to potentially contaminate other areas of the premises and other products manufactured in those areas.
5. Your plumbing is not adequately installed and maintained to provide adequate floor drainage, as required by 21 CFR 110.37(b)(4). Specifically, our investigator observed standing water in the Curwood Bake Room (formerly known as the Production Floor) along the south side of the chillers. A pallet of food was seen sitting in this puddle on the second day of the inspection with finished USDA product on it.
Also, water was seen pooled in the Work in Process Cooler (WIP) also on the second day of the inspection. A pallet/tote of food was also seen sitting in this puddle.
These areas are used to manufacture and hold products like Macaroni and Cheese. Any contamination could be transferred throughout the facility to potentially contaminate other areas of the facility and other products manufactured in those areas.
6. You failed to conduct cleaning of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a). Specifically, our investigator observed employees using high pressure hoses on the liquefying kettle with the lid open. The employees were spraying off the spillage of ingredients off the liquefying kettle located in the Kettle Room (formerly the Hot Fill Room). Our investigator observed this spray going directly into the opening of the liquefying kettle (holding Creamy Broccoli Chicken dinner, a USDA product). This happened on two occasions while our investigator was in the Kettle Cook Room (formerly the Hot Fill Room) within 15 to 25 minutes. The lid to the liquefier/kettle was never closed. The back of the lid opens to a little more than a (b)(4) degree angle acting as a backboard, assisting the spray overshoot to be directed into the opening while employees are spraying off the kettle with the high pressure hoses using cold water. While during the inspection, the liquefying kettle was holding USDA product, your firm's Bake Side Plant Manager informed our investigator the liquefying kettles are used to manufacture and hold USDA and FDA products (i.e. margarine and cream).
In addition, our investigator observed the lightening mixer located in the Kettle Room (formerly the Hot Fill Room) with large amounts of foreign material build-up underneath the housing area. This mixer was used to mix the ingredients in the (b)(4) carts prior to addition into the kettles. This is used for the manufacturing of the cheese sauce for the Macaroni and Cheese, like margarine and cream.
7. Your plumbing constitutes a source of contamination to food, water supplies, equipment, and utensils or creating an unsanitary condition, as required by 21 CFR 110.37(b)(3). Specifically, our investigators observed the hand sink a long the east wall in the Kettle Room (formerly known as the Hot Fill Room) was completely disconnected underneath and water running directly on to the floor where it came into contact with employee boots in the area where products like Macaroni and Cheese are manufactured.
Additionally, our investigator observed the utensil washing station in the "Vegetable Raw" room, where products like the Cheesy Macaroni Salad and various potato salads are manufactured, was also completely disconnected and able to run onto the floor where it came into contact with employee boots.
Moreover, our investigator observed the plumbing below the hand sink on the east wall of the Salad Mixing Room, where products like the Cheesy Macaroni Salad and various potato salads are manufactured, leaking water directly onto the floor where it came into contact with employee boots.
8. You failed to perform filling and packaging in a manner that protects food from becoming contaminated, as required by 21 CFR 110.80(b)(13). Specifically, our investigator observed black single-use consumer food contact packaging trays with water all over them, both on the inside and the outside of the trays. This water was reported by your firm's Quality Assurance Supervisor as coming from spraying out of the previous food material out of the hopper from the fill line in the Curwood Bake Room (formerly known as the Production Floor). In addition, our investigator observed employees were actively using these containers with visible water on them during production of the Creamy Broccoli Chicken dinner, a USDA product. These trays were located on the table next to the hot fill line in the Curwood Bake Room (formerly known as the Production Floor). Per your Bake Side Plant Manager, these trays are used for USDA and FDA products.
9. You failed to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination, as required by 21 CFR 110.35(d)(3). Specifically, our investigator observed, a plastic curtain dividing the Curwood Pack Off room and the Curwood Baking Room (formerly the Production Floor) was green with discoloration and appeared unclean. Products like Macaroni and Cheese, gravies and puddings are manufactured in this area of your plant.
The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of human food products, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. It is your responsibility to assure adherence with each requirement of the Act and the implementing regulations.
You should take immediate steps to attain compliance with the law. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
You should know that these serious violations of the law might result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure, and/or injunction.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. Are-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your response should be sent to Tamara J. Umscheid, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Dr., Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer, Tamara J. Umscheid at 913-495-5128.
Gerald D. Bromley Jr.
Acting District Director
Kansas City District Office