Ross R. Swanes
- Northern Fish Products, Inc.
Tacoma, WA 98409
- Issuing Office:
- Seattle District Office
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Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021
April 25, 2017
RETURN RECEIPT REQUESTED
In reply, refer to Warning Letter SEA 17-12
Ross R. Swanes, President
Northern Fish Products, Inc.
P.O. Box 9615
Tacoma, Washington 98409
Dear Mr. Swanes:
The United States Food and Drug Administration (FDA or we) inspected your seafood processing facility located at 3911 South 56th
Street, Tacoma, Washington, from October 24, 2016, through November 18, 2016. During the inspection, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental swabs identified the presence of Listeria monocytogenes
), a human pathogen, in your facility. We have determined that your raw, fresh, and frozen filleted or portioned fish, and your ready-to-eat (RTE) products such as imitation crab and hot-smoked fish 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 become contaminated with filth or rendered injurious to health. Additionally, review of documentation obtained during our inspection revealed that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123). In accordance with 21 CFR Part 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Act. You may find the Act, the seafood HACCP regulation, and the 4th Edition of FDA’s Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s home page at www.fda.gov.
We received your response letter, dated December 6, 2016, written in response to the Form FDA 483, Inspectional Observations, issued to you on November 18, 2016. We address your response below.
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 food contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, a 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.
FDA’s laboratory analysis of environmental samples INV952967 and INV952968 collected on October 24, 2016, and October 25, 2016, confirmed that nine (9) of one hundred sixty-four (164) environmental swabs from the manufacturing area, including areas adjacent to food contact surfaces, tested positive for L. monocytogenes. Specifically, one swab was collected from the legs of the smokehouse finished packing room countertop scale. An employee was observed moving this scale with his hands to the weighing table and then directly touching pieces of finished hot smoked RTE salmon, without washing his hands or changing gloves.
Whole Genome Sequence (WGS) analysis was conducted on the nine (9) L. monocytogenes isolates obtained from the positive FDA environmental samples collected during our inspection on October 24 and 25, 2016. 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 analyses of these nine (9) isolates found that they are comprised of five (5) strains of L. monocytogenes. 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 note that FDA laboratory analyses of samples INV952967 and INV952968 also identified thirteen (13) swabs collected throughout the facility that were positive for non-pathogenic Listeria species including L. innoca, L. welshimeri, L. seeligeri; one of the thirteen (13) swabs also tested positive for L. grayi. The positive swabs were collected from locations which could lead to the cross-contamination of food and food contact surfaces. Specifically, direct food contact surfaces including the top surface of a small metal scale, the top of a nylon cutting board, and a metal holding tote tested positive for L. welshimeri. Other environmental swabs that were positive for non-pathogenic Listeria species were collected on seals to the walk-in-cooler, the wheels of pallet jacks, the wheels of a stainless steel cart, a fork lift fork, and a floor drain surface. The presence of non-pathogenic Listeria species is indicative of insanitary conditions that are suitable for the survival and/or growth of the pathogen L. monocytogenes. We reviewed your response letter dated December 6, 2016, written in response to the Form FDA 483, Inspectional Observations, issued to you on November 18, 2016. Your response described actions that you have taken, including removing pallet jacks and carts from service that tested positive for L. monocytogenes, designating wheeled equipment and cleaning tools to color-coded zones to minimize cross-contamination, and installing (b)(4) dispensers throughout the facility for sanitizing wheels and foot traffic. However, we are unable to evaluate the adequacy of your corrective actions because the “Northern Fish Products Cleaning Schedule” provided with your response does not describe the cleaning methods, chemicals, and frequency for the cleaning of pallet jacks, fork lifts, or carts. We acknowledge your response in which you have committed to increased frequency of swab tests on both food contact and non-food contact surfaces, including testing of all drains every (b)(4). We acknowledge the results you submitted for environmental samples collected at nine (9) locations on November 14, 15, and 16, 2016, which were negative for Listeria. Based on FDA’s Listeria findings and observed insanitary conditions, FDA recommends that you consider developing written SSOPs for environmental sampling that define the frequency of sampling, locations for sampling, and the method of sample analysis to verify the success of your sanitation program. We will ascertain the adequacy of your corrective actions during our next inspection.
Seafood HACCP Violations
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR Part 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for hot smoked products at the refrigerated storage critical control point for RTE product lists a critical limit of “Refrigerated storage temperature must be no greater than ≤40°F for more than (b)(4) hours” that is not adequate to control pathogen growth and toxin formation. FDA recommends a critical limit that lists a refrigeration temperature of 40°F or below, which is to be continuous and without a time allotment.
2. Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your firm’s HACCP plan for hot smoked products at the refrigerated storage critical control point lists a corrective action of “If the cooler is above >40°F for more than (b)(4) hours, then segregate, chill, hold and label affected product and evaluate product based on total time temperature exposure (i.e.. microbiological testing), i.e. if core temperature of product is above >40°F, then product is discarded” that is not adequate to control pathogen growth and toxin formation. Evaluation of time temperature abuse should begin when the temperature exceeds 40°F, not after (b)(4) hours, as listed in your corrective actions. Also, product microbiological testing and core product temperatures are not appropriate for determining product disposition in response to an ambient temperature deviation of a cooler. FDA recommends product disposition be based on the cumulative total time and ambient temperature exposures for pathogen growth and toxin formation. We recommend referring to those time/temperature combinations listed in Table A-2 in Appendix 4 of the Fish and Fishery Product Hazard and Controls Guidance (4th ed.).
This letter is not intended to be an all-inclusive list of the violations that exist at your facility or 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 all applicable laws and regulations.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement or regulatory action without further notice, including, without limitation, seizure and injunction.
You should notify this office in writing within fifteen business days from the date you receive this letter and should describe the specific steps you have taken to correct these violations and to prevent these violations from recurring. Your response should include documentation of corrective actions you have taken to date. If your firm will not be able to complete corrective actions within fifteen business days, 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 should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Maria P. Kelly-Doggett, Compliance Officer. Refer to the identification number WL SEA 17-12 when replying. If you have any questions regarding any issues in this letter, please contact Compliance Officer Maria Kelly-Doggett by telephone at 425-302-0427.
Miriam R. Burbach
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560
cc: Seafood Inspection Program
USDC, NOAA, NMFS
1315 East-West Highway
Silver Spring, Maryland 20910
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