Inspections, Compliance, Enforcement, and Criminal Investigations

Trapper's Creek Inc. DBA Copper River Smoking Company 2/28/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021 

 

February 28, 2017
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply, refer to Warning Letter SEA 17-06
 
Andrea Wahry, President
Trapper’s Creek, Inc.
dba Copper River Smoking Company
240 15th Street SE #A
Puyallup, Washington 98372
 
WARNING LETTER
 
Dear Ms. Wahry:
 
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 240 15th Street SE #A, Puyallup, Washington, from August 29, 2016, through September 30, 2016. During the inspection, FDA collected environmental samples consisting of multiple swabs taken from various areas in your processing facility. FDA laboratory analysis of the environmental swabs identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Based on this analysis, we have determined that your hot-smoked salmon and salmon jerky 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 have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. Additionally, our inspection found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123)  and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).[1] 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 and cGMP regulations, 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.
 
The inspection of your firm resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483) on September 30, 2016.  We received a letter from your firm dated October 20, 2016, written in response to the Form FDA 483, Inspectional Observations. The adequacy of your firm’s response cannot be determined at this time. 
 
Presence of Listeria monocytogenes:
 
FDA investigators collected environmental samples from your processing facility on August 29, 2016, and August 30, 2016. FDA analysis of the environmental samples (774742 and 948527) confirmed that five (5) of one hundred ninety-four (194) environmental swabs were positive forpathogenic L. monocytogenes.  Specifically, these positive swabs include:
 
-          One (1) environmental swab collected from the food contact surface between the conveyer belt and the frame of the slicer used to cut raw fish for salmon jerky. 
 
-          One (1) environmental swab collected at the junction of old and new floor in front of smoker (b)(4). Racks of uncovered Ready-To-Eat (RTE) hot smoked salmon are rolled out of this smoker and over this area of the floor. 
 
-          Three (3) environmental subsamples collected from floor drains in the Raw Room where raw fish is thawed and filleted for hot smoked salmon and salmon jerky.
 
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.  Therefore, 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.  Consuming foods contaminated with Listeria 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.
 
Whole Genome Sequencing (WGS) analysis was conducted on the five (5) L. monocytogenes isolates obtained from the August 29, 2016, and August 30, 2016, FDA environmental samples.  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 of the referenced samples showed one strain of L. monocytogenes is present in your facility.  WGS analysis showed that all five (5) isolates are virtually identical to each other.  This may indicate a resident strain or niche harborage site in 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.
 
We note that FDA environmental samples (774742 and 948527) also isolated sixty-nine (69) swabs with non-pathogenic Listeria species including L. innocua, L. grayi, and L. welshimeri.  These positive swabs were found on direct food contact surfaces, brining equipment, and other areas where you manufacture jerky products.  The presence of non-pathogenic Listeria species is indicative of conditions that are suitable for the survival and/or growth of the pathogen L. monocytogenes.
 
We reviewed your written response, dated October 20, 2016, which indicates that a deep cleaning occurred on September 16, 2016, in combination with a modified Listeria Control Program and that you have implemented an extensive sanitation process.  You also indicated that you have completed consecutive Listeria species testing on September 19, 20 and 21, 2016, that focused on sub-sample numbers 12 and 14 with (b)(4) sampling through the next (b)(4) days. Additionally, your response indicated that you are working with a third party consultant and you are targeting December 1, 2016, as a completion date for updates and evidence of implementation to your SSOP, master sanitation and Listeria control program. At this time, we cannot determine the adequacy of your response without additional information and documentation. 
 
Seafood HACCP Violations
 
1.    You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for “Vacuum Packaged Smoked Salmon & Smoked Steelhead Trout” does not list the critical control point of thawing for controlling the food safety hazard of Clostridium botulinum. Your firm was observed thawing intact vacuum packaged frozen, raw salmon in the raw room for over (b)(4) hours without refrigeration prior to being moved into the raw cooler.  FDA recommends that firms ensure that thawing of raw vacuum packaged fish is conducted under proper refrigerated conditions (i.e., at or below 38°F) to control the hazard of Clostridium botulinum.   
 
2.    You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 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 “Vacuum Packaged Smoked Salmon & Smoked Steelhead Trout” does not list a critical limit for “Thickness of Fish” at the brining critical control point.  Specifically, your firm has identified fish thickness as the value that must be controlled and has referenced a difference between smallest and largest portions not to exceed (b)(4)., however there are no maximum or minimum values for actual thickness of fish to ensure that each piece of fish meets the critical limit for the final brine at this critical control point.  
 
3.    You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces and prevention of cross contamination with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110 as evidenced by observations including the following:
 
a.    Employees were observed entering the main offices, raw room, receiving area, receiving dock, employee break room, restrooms, production office and raw jerky area while wearing their street shoes, including tennis shoes. The employees were observed wearing the same shoes in the firm’s parking lot prior to entering these areas. Employees were also observed entering the Ready-To-Eat (RTE)/packaging area without changing their street shoes.  Additionally, employees were observed walking from the wooden hallway through the exit door of the RTE/Packaging Area without using the foot bath.
b.    Employees were observed entering the RTE/packaging area without washing or sanitizing their hands prior to handling food contact equipment and packaging material.
c.    An employee was observed using his bare arms to straighten film used to package ready-to-eat smoked salmon on the vacuum packaging machine.
d.    Employee smocks were observed stored in areas where they could become contaminated. For example,(b)(4), RTE/packaging smocks were observed hanging in the break room in direct contact with shoes and (b)(4) smock was observed in direct contact with the wheels of a scooter that holds baskets of ready-to-eat salmon jerky. In the area designated, “RTE SMOCKS ONLY”, (b)(4) smock was observed in direct contact with (b)(4), raw area smock. An employee was observed wearing (b)(4), RTE/packaging smock on the receiving dock while breaking down frozen, raw salmon.
e.    Pallet jacks labeled for designated areas were observed being used and stored throughout the facility. For example, a RTE ONLY pallet jack was observed being rolled outside, through a puddle onto the receiving dock to move totes of raw fish and then back into the RTE processing area without being cleaned and sanitized. The RTE ONLY pallet jacks were also observed stored in the raw area, the wooden hallway, and the receiving area. These pallet jacks were observed in direct contact with the raw room floor drain where FDA isolated L. monocytogenes.  Also, the pallet jack labeled “PACKAGING” was observed in the receiving area and wooden hallway before entering the RTE packaging area without being cleaned and sanitized.  FDA isolated L. welshimeri from the wheel of this pallet jack while it was in the RTE packaging area.  Food contact baskets were observed being cleaned with a red brush designated for the raw area.
f.     Cutting boards used to fillet raw fish were deeply grooved and stained. FDA isolated L. innocua from these cutting boards.
g.    The outbound conveyer belt on the raw fish slicer had a two inch tear in the middle of the belt and frayed edges. FDA isolated L. innocua from this conveyer belt.
 
Your written response, dated October 20, 2016, states that you are working with a third-party consultant to address and respond to the observations described above, which would include plan and program reassessments, employee training, and verifying effectiveness. However, your response provides no further details on what your corrective actions entail. Therefore, we cannot determine the adequacy of your firm’s corrective actions at this time.  
 
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 do so may result in regulatory action being initiated without further notice, including, without limitation, seizure and/or injunction.
 
In addition to the violations listed above, we are providing the following comment on your seafood HACCP program: 
  • On September 7, 2016, your firm was found using expired calibration standards in water activity testing of your RTE finished product of jerky. The (b)(4) calibration standards, used to calibrate the (b)(4) model water activity meter, expired in June 2016. These standard vials are used to perform (b)(4) calibration of the (b)(4) brand water activity meter used to test water activity for each batch of finished product jerky. According to CCP #2 “Smoking/Drying” on your “HACCP Plan for Vacuum Packaged Salmon Jerky Regular, Peppered, Teriyaki, Orange Ginger,” prevention of production of C. botulinum and S. aureus toxin in the finished product is achieved by successful completion of the jerky process to achieve a water activity of (b)(4) or less. Due to the expired calibration standards, the water activity for all finished product jerky introduced into interstate from June 2016 to the current inspection cannot be verified. 
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.
 
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 actions before you respond, please state the reason for the delay and include a timetable for implementation of those corrections.
 
Your firm’s response 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 17-06 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. 
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
cc:     
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560       
Olympia, Washington 98504-2560
 
Seafood Inspection Program
USDC, NOAA, NMFS
1315 East-West Highway
Silver Spring, Maryland 20910 


[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size.   See http://www.fda.gov/Food/GuidanceRegulation/ FSMA/ ucm334115. htm#Compliance_Dates for PC rule compliance dates.

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