- Reser's Fine Foods Inc.
- Issuing Office:
- Atlanta District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Atlanta District Office|
60 8th St., NE
Atlanta, GA 30309
July 1, 2016
VIA UPS OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Mark A. Reser, President & CEO
Reser’s Fine Foods, Inc.
15570 SW Jenkins Road
Beaverton, OR 66607
Dear Mr. Reser,
The U.S. Food & Drug Administration (FDA) inspected your refrigerated ready-to-eat (RTE) salad manufacturer facility located at 11251 NC Highway 903, Halifax, NC 27839-9073 on November 3 through 10, 2015. During our inspection, FDA collected environmental samples from various areas in your processing facility, including areas that are in close proximity to food and food contact surfaces. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).
Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we determined that your food products are 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 were 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
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s response dated November 25, 2015, to the FDA-483, which includes a description of corrective action taken by your firm. However, your response does not fully address the violations observed during the inspection.
Presence of Listeria
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 a severe, sometimes life-threatening illness called listeriosis, a 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 the environmental samples (FDA 910789, FDA 910790, and FDA 910791) collected on November 3-5, 2015, confirmed that six (6) environmental subsample swabs were positive for L. monocytogenes. Specifically:
- Four (4) of the environmental swabs were collected from inside the Processing Room on various locations, including a direct food contact surface. These areas include:
o Inside of a v-mag, a food contact surface, used to carry potato salad to the filler for packaging.
o A v-mag wheel, which was located adjacent to a line used for holding potato salad
- One (1) environmental swab was collected in the WIP II Room from the inside lip of a plastic tote used to store product
- One (1) environmental swab was collected in the Finished Potato/Macaroni Room from an I-beam above the potato conveyor.
Furthermore, this was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for L. monocytogenes. Environmental samples (FDA 821317 and FDA 821318) collected during our 2013 inspection revealed L. monocytogenes in six (6) environmental subsample swabs in various locations within your facility, including in floor gaps, wheels of forklift and carts that are moved throughout the facility, and floor drains. Additionally, an environmental sample (FDA 862365) collected during our 2014 inspection revealed L. monocytogenes in two (2) environmental subsample swabs in locations within your facility, including on the wheel of a fork lift and v-mag number.
Whole Genome Sequencing (WGS) analysis was conducted on six (6) L. monocytogenes isolates obtained from the FDA environmental samples collected in November 2015, two (2) L. monocytogenes isolates obtained from the FDA environmental samples collected in August 2014, and six (6) L. monocytogenes isolates obtained from the FDA environmental samples collected in November 2013. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. The WGS phylogenetic analysis found that there are at least three (3) different strains of L. monocytogenes present in the facility. The WGS results show that one (1) of these strains includes isolates that have been found over a period of time. Specifically, four (4) of the environmental isolates collected in November 2015, one (1) of the environmental isolates collected in August 2014, and four (4) of the environmental isolates collected in November 2013, were identical by WGS analysis.
The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since November 2013. The reoccurring presence of identical strains of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
Furthermore, L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated. Once established in a production area, humans or machinery can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. FDA acknowledges that one of the environmental swabs from the November 2015 inspection that tested positive for L. monocytogenes was taken from a food contact surface used to carry potato salad. As a result of this finding, your firm conducted a voluntary recall on December 1, 2015 of a single lot of potato salad product.
Additionally, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. Your firm failed to ensure that cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR Part 110.35(a). Specifically, our investigators observed:
- During processing of (b)(4) Pasta Salad on Line (b)(4), what appeared to be pieces of imitation crab remained on the equipment from the previously-run (b)(4) Salad that contained the allergens of fish (Pollock) and crustacean shellfish (crab);
- During processing of (b)(4) Potato Salad on Line (b)(4), what appeared to be pieces of macaroni that remained on the equipment after processing of (b)(4) Salad that contained the allergen of wheat;
- During processing of (b)(4) Salad on Line (b)(4), what appeared to be pieces of imitation crab remained on equipment from the previously-run (b)(4) Salad that contained the allergens of fish (Pollock), wheat (wheat starch), and shellfish (snow crab).
- Food contact paddle used to move finished potato salad from v-mags into the hopper on the filling line, was observed to be hanging against a sanitizer hose that was previously observed being dragged across the floor.
- Puddled water was observed on the plastic covering the v-mags in the WIP I/Mixing Room that contained finished product waiting to be packed. Your Plant Manager stated the puddles were overspray from the previous night’s sanitation shift cleaning the mixers and the room.
Your firm’s response indicates that implicated products have been discarded, retraining was conducted on cleaning procedures, and corrective actions were made to address other sites for potential contamination. However, your response failed to include information on product sequencing based on the different types of allergens present in your various products, or a detailed sanitation program, to include use of a detergent, demonstrating adequate cleaning and sanitizing to avoid allergen cross-contact. We will ascertain the adequacy of your corrective action during our next inspection.
2. Your firm failed to ensure that equipment and utensils are maintained in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR Part 110.80(b)(1). Specifically our investigators inspected the processing equipment after plant management had completed their sanitation review prior to processing, their observations revealed:
- A build-up of product in the filler head ports on filler Line (b)(4);
- Loose food material on the filler equipment on Line (b)(4);
- A build-up of product in the hopper ports on filler Line(b)(4);
- A build-up of material between hopper holes 2 and 3 in a gap in the valve casing on filler Line (b)(4);
- A build-up of food and organic material in the electrical box next to the filler on filler Line (b)(4);
- A slimy build-up around the drain holes in the machine housing under the filler on filler Line (b)(4);
- A build-up of food material between the lid and the top spinning plate on the cabbage centrifuges;
- A build-up of cheese on the inside of the extruder casing on the cheese grinder used to grind cheese product for pimento cheese;
- A build-up of cheese in between the extruder casing on the cheese grinder and the cheese grinder;
- A build-up of food particles on the star wheel slicer on the cheese grinder;
- A build-up of cheese underneath the bowl on the cheese hopper used to chop and mix cheese product for pimento cheese.
Your firm’s response indicates that you have cleaned and sanitized your processing equipment and conducted special sanitation training. However, inadequate sanitation is a repeat observation from our November 5-13, 2013 inspection. Your firm’s response failed to include information to demonstrate how future product residue in and on equipment would be prevented or provide other assurance the promised corrections would ensure a lasting correction of the violation.
3. Your firm failed to ensure the plant equipment and utensils are designed to allow for adequate cleaning and proper maintenance, as required by 21 CFR Part 110.40(a). Specifically our investigators observed the following:
- The extruder on the pimento cheese grinder does not seal. As a result, pimento cheese product accumulated between the grinder extruder and the grinder. Cheese product was observed spilling from the seal on the extruder on the cheese grinder and a build-up of cheese product was observed between the cheese extruder and the cheese grinder after being cleaned and sanitized.
- The food contact surface on the extruder head of the cheese grinder and filler valves/plungers on the finished product fillers were observed to be rusted, chipped, pitted and nicked.
Your firm’s response includes that action was taken to clean, sanitize, and/or replace your processing equipment. However, comprehensive assurances where not provided address what preventative measures your firm will take to insure that the proper maintenance of your processing equipment. We will ascertain the adequacy of your corrective action during our next inspection.
4. 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 Part 110.20(b)(4). Specifically, our investigators observed the cooling unit condensate holding tray dripping condensate onto Line (b)(4) which was packaging (b)(4) Salad and in the warehouse frozen storage room adjacent to finished product storage. Additionally, dripping condensate was observed in the Mixing Room adjacent to v-mags holding cooked potatoes.
Your firm’s response indicates that a root-cause evaluation was performed which appears to have identified the causes of the noted violations. It also appears that your firm has taken corrective actions to address the noted deficiencies and any implicated product has been destroyed. We will ascertain the adequacy of your corrective action during our next inspection.
5. Your firm failed to take effective measures to protect against the inclusion of metal and other extraneous material in food, as required by 21 CFR Part 110.80(b)(8). Specifically, our investigator observed:
a. A number of metal parts including nuts, screws, bolts, washers, and rods on the floors around where open products were being processed.
b. Broken and loose plastic pieces on the cabbage washing conveyor belt just prior to the start of cabbage washing operations; repairs were not conducted or otherwise addressed following cleaning and sanitation procedures.
Your firm’s response indicates that these metal objects have been removed from your processing floors, your pre-operational inspection and the production pre-shift check lists were amended to capture these deficiencies, and staff training was conducted. However, your response does not identify the cause of this violation or address how to you will prevent future recurrence of this violation.
This letter is not intended to be an all-inclusive list of violations that exist in connection with your products. It is your responsibility to ensure that your products are in compliance with the Act and all applicable regulations, including the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110].
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement action by the FDA without further notice. 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 FDA’s costs for certain activities, including re-inspection-related costs. A re-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 respond in writing within fifteen (15) working days of receiving this letter. Your response should outline the specific steps you are taking to correct these violations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions your firm has taken. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed.
Your response should be sent to Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, NE, Atlanta, GA 30309. If you have any questions about this letter, please contact Compliance Officer, Janice King at 843-746-2990 or Janice.email@example.com.
Ingrid A. Zambrana
Atlanta District Office
Mr. Kenneth R. Braswell, General Manager
Reser’s Fine Foods, Inc.
11250 NC Highway 903
Halifax, NC 27839