First, the letter points out that FDA found 19 Listeria positive environmental samples with 7 of those being food contact surfaces including a chiller water system (that did not have sanitizer). These samples were linked via Whole Genome Sequencing to clinical isolates. While the firm corrected the facility issues, FDA stated that this was not enough. "While we acknowledge these are appropriate actions to be taken, we are unable to fully evaluate the adequacy of these actions at this time without further details, documentation and results of your corrective actions." So basically, they want to see results from extensive sampling, including when the plant is operating, that the organism is not present.
On GMP issues, the facility was found to be not as clean as it should have been. While the plant indicated it trained the employees, FDA found the response lacking. ."your response did not provide any details as to the content of this training or how you will ensure this training is effective by assessing and monitoring employee performance and adherence to the training."
The facility had many condensation issues, which is not good from controlling Listeria. While the facility responded that they fixed sources of condensation, FDA responded "how you will assess whether this correction and the [fixes] 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."
The facility had poorly made food contact surfaces that would provide harborage. While the facility had repaired the surfaces, FDA responded "you provided no documentation or details on how you will ensure the repairs are adequate. Your response does not address how you will prevent future recurrence of this violation. "
In addition, there were steam ventilation issues and general facility issues. Again, fixes were made, but the outcome of those fixes and measures to prevent reoccurrence were not addressed.
FDA Warning Letter
Oregon Potato Company 7/15/16
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021
Telephone: 425-302-0340 FAX: 425-302-0402
July 15, 2016
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
In reply, refer to Warning Letter SEA 16-14
Frank Tiegs, President
Oregon Potato Company
dba Freeze Pack
302 N. Venture Road
Pasco, Washington 99301
WARNING LETTER
Dear Mr. Tiegs:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 302 N. Venture Road, Pasco, Washington, from March 8, 2016, through March 11, 2016. During the 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 analysis of the environmental swabs identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA investigators observed violations of Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).[1] Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we determined that your Individually Quick Frozen (IQF) produce, including onions, 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 can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
This inspection resulted in FDA’s issuance of a FDA Form-483, Inspectional Observations, at the conclusion of the inspection. We acknowledge your firm’s responses, including correspondences received dated March 24, 2016; March 30, 2016; and May 11, 2016, which include a description of corrective action taken by your firm. However, your response does not fully address the violations observed during the inspection. After review of the inspectional findings and your firm’s response, your firm’s significant deviations remain as follows:
Pathogen Findings
FDA’s laboratory analysis of environmental samples collected on March 8, 2016, and March 9, 2016, confirmed that nineteen (19) of one hundred and six (106) environmental swabs tested positive for L. monocytogenes. Specifically:
- Seven (7) positive environmental swabs were collected from direct food contact surfaces in both your Processing and Packaging Rooms during the production of your IQF diced onions. These direct food contact surface areas include:
- The chiller water and the interior north wall of the water chiller. Water from this chiller is not treated and is recirculated back to the blancher/chiller and used directly on blanched diced onions as a coolant;
- A white nylon strip in the tunnel discharge chute between the IQF freezer and the finished product Packaging Room. Blanched, finished product is conveyed and comes into direct contact with the nylon strip; and
- The metal arm on your chain conveyor belt between the IQF freezer and Packaging Room where blanched, finished product is conveyed directly on this conveying system and comes into contact with the metal arm.
- The remaining twelve (12) positive environmental swabs were collected from locations in your Processing room and your Packaging Room that were in areas adjacent to food contact surfaces and non-direct food contact surfaces.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming this contaminated food can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.
The referenced environmental samples were further analyzed using Whole Genome Sequencing (WGS). 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. WGS analysis was conducted on the nineteen (19) L. monocytogenes isolates obtained from the FDA environmental samples collected on March 8, 2016, and March 9, 2016. The WGS phylogenetic analysis establishes that there are at least two (2) different strains of L. monocytogenes present in the facility, with one strain containing seventeen (17) isolates and the second strain containing two (2) isolates. Specifically, the WGS analysis of the strain with 17 isolates showed that the isolates are identical to each other. WGS analysis of the strain with 2 isolates showed that the isolates are identical to 8 cases of human illness dating back to 2013, and to 6 isolates from finished products. These finished products included onions (2 isolates in 2014) and green beans (3 isolates in 2015) tested by a third party laboratory, and a single isolate from white sweet corn collected and tested by the state of Ohio in 2016. Additional investigation established that at least six (6) individuals were hospitalized as a result of related L. monocytogenes associated illness.
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 generally and on your processing equipment specifically to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires expert knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to eliminate this pathogen. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take necessary corrective actions to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
We received a response via email from Craig A. Bolt, Plant Manager, on March 30, 2016, concerning the results of the environmental testing discussed with your firm on March 29, 2016. We acknowledge that you ceased production to clean and sanitize all surfaces in the facility. Additionally, your response indicates that your firm is implementing a number of corrective actions, including stripping all of the corroded flashing at the floor-wall junctures and cleaning and sanitizing the exposed surfaces before installing new flashing; removing and replacing plastic curtains with new material; increasing the size of your sanitation staff, revising your environmental testing procedure to include more sites and to be more robust, and working with your chemical supplier to support correct chemical applications and cleaning procedures; and installing a central sanitizing system, which would include (b)(4). While we acknowledge these are appropriate actions to be taken, we are unable to fully evaluate the adequacy of these actions at this time without further details, documentation and results of your corrective actions. We note that your response did not provide a timeframe for completion or for resuming operations.
cGMP Violations
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 all food-contact surfaces, including utensils and food-contact surfaces of equipment, are cleaned as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically, our investigator observed food and accumulated debris on food contact surfaces in the Preparation, Processing, and Packaging room after your firm completed the pre-operational sanitation check and equipment was considered ready for processing. In the Preparation room, food debris was observed on the conveyor belts which convey whole onions through the “(b)(4)” line, the interior surface of the onion slicing machine, the conveyor belts which convey diced onions, and the dicing blades and the cylinders used to hold the dicing blades. In the Processing room, debris, and in some instances grime, was observed on conveyor belts, the interior walls of the onion chiller hood, and the ceiling of the IQF tunnel. In the Packaging room, debris was observed on the conveyor belt leading to the tote packaging area and the incline belt leading to the (b)(4) metal detector.
Your firm’s response indicates that all sanitation and pre-operation inspection personnel were retrained on proper and thorough cleaning, and you provided a training roster. However, your response did not provide any details as to the content of this training or how you will ensure this training is effective by assessing and monitoring employee performance and adherence to the training. Your response also indicates that your Sanitation Lead employee is responsible for the corrective action; however, your response did not identify the trainer, nor did this individual’s name appear on the training roster. Additionally, your response does not address how you intend to prevent this violation from recurring.
2. 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.
3. Your firm failed to ensure that seams on food-contact surfaces are smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms, as required by 21 CFR 110.40(b). Specifically:
- Blanched, diced onions were observed in direct contact with rough welds inside the blancher/chiller (b)(4) in the processing room and on the interior of the (b)(4) chute on the west end of the blue conveyor belt in the processing room. Moreover, L. monocytogenes was found on the blancher/chiller (b)(4).
- Blanched, diced onions were observed in direct contact with rough welds on the interior of the IQF (b)(4) in the processing room.
- Frozen, rework blocks of onions were observed in direct contact with the rough welds of three custom-made, (b)(4) utensils used to break apart the blocks of onions.
Your firm’s response indicates that you will replace the (b)(4) chute of the blue conveyor belt on March 21, 2016; however, none of the photographs provided with your response appear to document this correction. Your response also indicates that you will repair all rough welds and replace the custom-made (b)(4) utensils; however, you provided no documentation or details on how you will ensure the repairs are adequate. Your response does not address how you will prevent future recurrence of this violation.
4. Your firm failed to ensure that your plant and facilities provide adequate ventilation or control equipment to minimize vapors (including steam) in areas where they may contaminate food, as required by 21 CFR 110.20(b)(6). Specifically, a thick accumulation of steam was observed in the processing room due to blanching operations. The steam was observed blanketing manufacturing equipment and blanched, diced onions.
Your firm’s response indicates that you will (b)(4) to control steam. However, you provided no additional details or documentation, such as how you will ensure (b)(4) is adequate to control steam and how you will monitor its effectiveness. Your response does not address how you will prevent recurrence of this violation.
5. Your firm failed to maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in repair sufficient to prevent food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.35(a). Specifically:
- Non-food contact surfaces in the packaging room were observed with accumulated debris and grime after your firm completed the pre-operational sanitation check. For example, the floor drain directly underneath the packaging chute at (b)(4) and areas around and behind the control boxes located on the east wall of the packaging room were observed with accumulated debris and grime and was found to be positive for L. monocytogenes.
- Non-food contact surfaces in the preparation room were observed with food debris after your firm completed the pre-operational sanitation check and the equipment was considered ready for processing. For example, the control box of the "(b)(4)” line contained food debris, including a whole onion.
- Non-food contact surfaces in the processing room were observed with accumulated debris and grime after your firm completed the pre-operational sanitation check. For example, the IQF freezer walls, floor, and floor-wall junctures were observed with accumulated debris and grime. The IQF freezer floor was observed with cracks and the floor-wall junctures were damaged in multiple areas.
Your firm’s response again indicates that all sanitation and pre-operation inspection personnel were retrained on proper and thorough cleaning and you provided a training roster. However, your response provided no details as to the content of this training or how you will ensure this training is effective by assessing and monitoring employee performance and adherence to the training. Your response included photographs without captions or labels that presumably indicate some cleaning of non-food contact surfaces has occurred following the inspection. However, your response does not address whether your firm limited cleaning to the areas specifically observed by the investigators or whether you assessed all areas of your facility and determined the need for thorough cleaning. Your response states that you will repair the damaged walls in all (b)(4) production rooms and repair the inside surfaces of the freezer by June 15, 2016. Your response does not indicate how you will keep these areas clean and sanitary in the interim. Your response states that you will retrain forklift drivers; however, no details of this training are provided and, as discussed above, your response does not address how you will ensure the training is effective. Additionally, your response does not address how to you will prevent recurrence of this violation.
Recall Classification
FDA acknowledges that your firm conducted a voluntary recall and considers the following IQF and fresh onion products, manufactured from March 8, 2016, to April 8, 2016, that your firm recalled beginning on April 6, 2016, to have posed an acute, life-threatening hazard to health: IQF 1/4" Yellow Onion Dice- Frozen; IQF 3/8" Yellow Onion Strip; IQF 3/8" Unblanched Yellow Onion Dice- Frozen; IQF 3/4" Yellow Onion Dice- Frozen; IQF 1/4" Frozen White Onion Dice; Fresh 3/8" White Onion Dice; Fresh 3/8" White Onion Strip; IQF 1/4 x 1/4 Yellow Onion Dice; and IQF 3/8" Yellow Onion Dice.
The FDA has designated your recall as Class I. This classification is based on findings by the FDA of Listeria monocytogenes in the manufacturing environment, including food contact surfaces. Furthermore, as stated above, WGS analysis was able to indicate that there were clinical isolates closely related genetically to the environmental isolates. Information regarding your recall will be published in the weekly FDA Enforcement Report. The FDA’s policy regarding recalls is published in 21 CFR Part 7. Our Seattle District Office Recall Coordinator will remain in contact with you until this matter is resolved.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to properly correct these violations and implement lasting corrective action of these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
We note that your firm’s response included the environmental sample results of the sister samples taken by your firm alongside FDA sampling. The results of your firm’s environmental sampling were all negative for Listeria. Given that FDA’s sampling revealed nineteen (19) environmental swabs that tested positive for L. monocytogenes, we are concerned with the adequacy of your sampling program. Your response included the general protocol reference guide for the method utilized by your laboratory. However, your firm did not provide detailed documents on the actual laboratory method that was performed to provide a comprehensive review of this issue. These documents would include, but are not limited to, analytical worksheets for these samples, information on date and time when the enrichment was in and out, what swab/sponge was used, what the exact procedure was for sampling, QA/QC data for method performance, media used for assays, reagents used in assays, and the assay worksheets for the samples taken March 8 and 9, 2016, and subsequently analyzed by your analytical services. After reviewing your response we note that several factors, including, but not limited to, sampling technique in the plant and enrichment procedures, can impact the results of the testing. Additionally, while your response states that you are planning a more robust environmental monitoring program, it does not address whether you will do this in consultation with individuals with expertise in this area.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations from recurring or other similar violations from occurring. You should include documentation of corrective actions you have taken to date. If your firm will not be able to complete corrective action before you respond, please state the reason for the delay and include a timetable for implementation of those corrections.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Your reply to the noted violations should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Jessica L. Kocian, Compliance Officer. Refer to the identification number WL SEA 16-14 when replying. If you have any questions regarding any issues in this letter, please contact Compliance Officer Jessica Kocian by telephone at 425-302-0444.
If you have any questions regarding the recall classification, please contact Seattle District Recall Coordinator Anh Trinh Nguyen by telephone at 425-302-0467.
Sincerely,
S/
Miriam R. Burbach
District Director
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560
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