- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NamePaul Packer
- Northeast Seafood Products, Inc.
4555 Kingston St
Denver, CO 80239-3016
- Issuing Office:
- Office of Human and Animal Food Operations Division West 4
March 24, 2022
Blair T. Joyce, Co-Owner/Vice-President
Scott M. Packer, Co-Owner/Treasurer
Ref: CMS Case #621620
Dear Messrs. Packer and Joyce:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 4555 Kingston St., Denver, Colorado, on September 21, 22 - 23, 27– 29, and October 14 and 19, 2021. The inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Thompson (S. Thompson) illnesses linked to seafood. According to the Centers for Disease Control and Prevention (CDC), 116 people from 14 states were infected with the outbreak strain of S. Thompson. On October 8, 2021, your firm recalled certain types of fresh seafood processed at your facility and distributed from May 2021 to October 7, 2021, because they had the potential of being contaminated with Salmonella. CDC and FDA have determined, based upon the epidemiologic, laboratory, and traceback evidence, that fresh seafood processed at your facility was the source of this multistate S. Thompson outbreak.
During our inspection we collected environmental samples (swabs) from various areas in your facility, including areas that are near food during processing operations. FDA laboratory analyses found the presence of the outbreak strain of S. Thompson, a human pathogen, in your facility. Additionally, FDA found 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) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
In accordance with 21 CFR 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 and fishery products adulterated with the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Based on our inspectional results, including review of FDA’s environmental testing and your HACCP plan, we have determined that the blue fin tuna and other fresh seafood processed by your firm are adulterated within the meaning of section 402(a)(4) of 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. You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA 483), Inspectional Observations. You provided responses to the inspection and sample findings via email on November 1, 9, 17, and 19, 2021, which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns with your current sanitation and HACCP programs as further described in this letter.
Salmonella species are not endemic to seafood; therefore, FDA expects zero or non-detectable levels of Salmonella in seafood regardless of whether it is intended to be cooked before consumption or it is ready-to-eat (RTE). Salmonella in seafood is the result of human or animal fecal contamination of the harvest waters and/or fecal contamination during post-harvest handling and processing. The contamination can also be exacerbated by temperature abuse. Raw RTE seafood must have appropriate controls from harvest to consumption. Symptoms of infection can range from gastroenteritis (e.g., diarrhea, fever, and stomach cramps) that is self-limiting (i.e., resolves without treatment), to chronic health problems and hospitalization with life-threating illness. Although all age groups are susceptible to Salmonella infections, young children, the elderly, and those with weakened immune systems are more likely to have severe infections. Many strains of Salmonella have a very low infective dose, making prevention critical.
FDA laboratory analysis of the environmental sample 1159734, collected on September 22, 2021, during the production of your fresh fish that is intended to be eaten raw or cooked by the consumer, confirmed thirteen (13) of 132 environmental swabs were positive for S. Thompson. The positive swabs were collected from various non-food contact locations in close proximity to areas where fish are processed in your facility, including the production room floor near processing and packaging equipment, floor drains in the production room, the leg of a stainless-steel processing table, and the shelf of a stainless-steel processing table. When product is exposed to the environment, inadequate sanitation and poor employee practices may lead to product contamination with pathogens in the environment, like Salmonella. If the contaminated fish is consumed raw or without being cooked adequately to sufficiently kill the pathogen, then people who consume the contaminated product may become ill.
The FDA conducted whole genome sequencing (WGS) analysis on the thirteen (13) Salmonella isolates obtained from environmental sample 1159734. The WGS analysis determined that the isolates derived from the environmental sample were a genomic match with each other and matched the clinical isolates from an outbreak that occurred in 2020 as well as the 2021 outbreak referenced above. We advised you of the WGS results via a conference call on October 7, 2021.
Although no environmental samples were collected from your firm prior to 2021, the following evidence suggests the outbreak strain was present in your facility as early as 2020. As mentioned, the WGS analysis determined the isolates derived from environmental sample 1159734 were a genomic match to clinical isolates in the 2020 outbreak. In addition, this particular strain of S. Thompson has not been identified elsewhere in the WGS database. During the 2020 and 2021 outbreaks, the majority of illnesses involved Colorado residents with similar onset dates of June 2020 to September 2020, and May 2021 to September 2021, respectively. You solely distribute your seafood products within Colorado, and sushi was the suspect vehicle for the 2020 outbreak. Furthermore, the insanitary conditions observed during the current inspection, along with the environmental swabs positive for Salmonella collected in various areas of your processing facility, increase the likelihood that pathogens can spread to food-contact surfaces or directly to RTE fish.
These positive Salmonella findings and the associated outbreaks indicate that your firm is neither achieving satisfactory control against the presence of Salmonella within your facility nor implementing effective methods and controls to eliminate this human pathogen and protect food and food-contact surfaces from contamination. You should perform a comprehensive root-cause analysis to identify potential sources and routes of contamination and implement adequate corrective actions based on your findings. A comprehensive root-cause analysis should evaluate all potential sources and explain the basis for their elimination, including actions such as reassessment of your environmental testing program, review of sanitation procedures and monitoring records, observing employee practices and monitoring procedures, and review of traffic patterns and equipment layout. The root-cause analysis and associated corrective actions should demonstrate that all sources and potential routes of contamination have been identified and corrected to ensure future product is not contaminated. If the likely source of contamination cannot be identified, then the root-cause analysis should thoroughly investigate and evaluate all potential sources and implemented controls. Your response to this warning letter should include your comprehensive root-cause analysis and corrections made based on the root-cause analysis that ensure your food is not adulterated by Salmonella. These corrective actions should be in addition to the corrective actions which were taken immediately after you were notified of these Salmonella findings and associated outbreaks.
During the October 7, 2021, conference call, you voluntarily agreed to recall seafood processed and distributed by your firm from May 2021 through October 7, 2021. You issued a press release on October 8, 2021, notifying your customers and retail consumers of your recall. You also voluntarily ceased processing operations at your facility on October 7, 2021, to implement corrective actions to address the presence of S. Thompson in your facility. Further, you hired a consultant to revise your environmental monitoring program (EMP) and sanitation procedures. You stated the consultant would assist with a root-cause analysis for the presence of Salmonella; however, you have not provided any documentation regarding the root-cause analysis except your revised EMP and your swabbing results for Salmonella. Although your environmental swab results were negative for Salmonella, testing alone is not sufficient to demonstrate you have removed all sources and routes of a resident strain of S. Thompson from your facility.
We have reviewed your completed and planned corrective actions. Your revised EMP now includes increased (b)(4) swabbing for Salmonella and pathogenic E. coli (EHEC/pSTEC) in addition to, Listeria. You have not submitted supporting documentation demonstrating the implementation of the EMP, which was planned for November 15, 2021. We note that the sample results you submitted (b)(4) environmental samples collected on (b)(4)) were taken prior to the resumption of your processing operations and do not reflect the implementation of your EMP. We also recommend the following regarding your revised EMP: ensure the test method used has been validated on environmental surfaces, include a list and/or map of sampling collection sites, and include additional details regarding results interpretation. You also provided a production room sanitation checklist. However, you have not provided completed sanitation monitoring records demonstrating that you have implemented your revised sanitation procedures.
You have indicated that you did not resume operations at your facility until you completed facility repairs and conducted additional environmental swabbing. You should continue to implement the necessary controls and procedures to ensure foodborne pathogens do not contaminate your seafood food products.
Your significant deviations are as follows:
1. You must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), that are both appropriate to your plant and the food being processed and relate to one of the areas specified in 21 CFR 123.11(b)(1)-(8), to comply with 21 CFR 123.11(b).
A. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that cleaning and sanitizing of utensils and equipment was conducted in a manner that protected against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). This is related to the condition and cleanliness of food-contact surfaces, 21 CFR 123.11(b)(2). Specifically,
i. On 9/22/2021, an employee in the processing room was observed using a high pressurize hose to spray the bottom shelf of a stainless-steel table to remove scales and debris during production hours. Spray was observed to hit the floor and the table, creating back-splash; a swab (#98) from that shelf tested positive for Salmonella.
ii. On 9/23/2021, an employee in the (b)(4) room ((b)(4) room) was observed using the (b)(4) high pressure hose to clean the floors with shellfish in the room; back-splash was observed contaminating the outside of the product packaging of product being stored on pallets in plastic containers or in cardboard/(b)(4) boxes.
iii. On 9/27/2021, during sanitation operations, an employee was observed using their gloved hand to remove water from the east floor drain under the processing sink in the processing room. The employee then proceeded to touch clean cutting boards and stainless-steel tables without washing hands and replacing gloves.
iv. On 9/27/2021, during (b)(4), a (b)(4) high pressure hose was used to clean the floor, and back-splash was observed on the food contact surfaces of the black ice carts.
v. On 9/27/2021, during (b)(4) shift, the concentration of a new sanitizer solution used to store in-use utensils was observed at 0 PPM.
vi. On 9/27/2021, during (b)(4) shift, apparent fish remnants and scales were observed on cutting boards that were documented during the pre-operation and post-operation inspections on the “(b)(4) Sanitation Report” as “clean and sanitary” after (b)(4) shift sanitation activities were completed.
vii. On 9/28/2021, an employee was observed to retrieve a black ice cart and move it to the (b)(4) room to place ice in the cart without cleaning and sanitizing it; swab # 126, positive for Salmonella, was collected from a black floor mat within an estimated six feet of where these carts were stored.
B. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that food-contact surfaces are maintained to protect food from being contaminated by any source, including unlawful indirect food additives, as required by 21 CFR 117.40(a)(6). This is related to prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, 21 CFR 123.11(b)(3). On 9/27/2021, during the (b)(4) shift, in the staging area, black ice carts were observed stacked on their sides and coming in contact with the floor and wheels of other carts, contaminating the inside of the carts (food contact surfaces).
C. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that drip or condensate from fixtures, ducts and pipes does not contaminate food, as required by 21 CFR 117.20(b)(4). This is related to the protection of food, food packaging materials, and food contact surfaces from adulteration with condensate, 21 CFR 123.11(b)(5). On 9/22/2021, condensation was observed dripping from the evaporator in the (b)(4) room onto the food contact surface of large gray bins used to store fresh fin fish.
D. You failed to monitor the conditions and practices during processing with sufficient frequency to ensure that all plant equipment and utensils used in manufacturing, processing, packing, or holding food are adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1). This is related to condition and cleanliness of food contact surfaces, 21 CFR 123.11(b)(2).
i. On 9/22/2021, both histamine and non-histamine cutting boards were observed to be worn and have deep cuts in plastic, making them more difficult to properly clean and sanitize.
ii. On 9/22/2021, bins and carts used to store fresh fin fish and ice were observed to be worn, chipped and damaged, making them more difficult to properly clean and sanitize.
2. Sanitation control records must document the monitoring and corrections prescribed by 21 CFR 123.11(b), and information must be entered at the time it is observed, to comply with 21 CFR 123.11 (c). However, your sanitation control records did not contain actual conditions, and observations were not entered at the times observed. Specifically:
A. Your sanitation records titled “(b)(4) Sanitation Report,” completed on (b)(4), and (b)(4), indicated that all monitored areas of sanitation were “okay” when the above insanitary conditions were observed.
B. On 9/27/2021, the (b)(4) shift “(b)(4) Sanitation Report,” which had entry times of (b)(4) and (b)(4), was observed to be completed entirely after the shift, not while the observations were made, and did not list the actual conditions and corrective actions on the form.
C. On 9/28/2021, the pre-operation inspection was completed approximately 30 minutes after production began around (b)(4).
Your November 9, 2021, response indicated that you are revising your sanitation program and implementing additional procedures and checklists addressing accurate completion of forms, sanitary operations for decanting raw fish and seafood, hand washing and glove use, and pre, mid-shift, and post operational checklists. You indicated that these procedures and checklists would be completed by November 15, 2021, and implemented once staff was trained. You have not provided supporting documentation demonstrating that your staff has been trained on the new procedures and checklists or that the procedures and checklist have been implemented.
Your responses dated November 9 and 17, 2021, detail the corrective actions you have taken to address the positive sample results and inspectional observations. The corrective actions include hiring a food safety consultant to assess and revise your operation procedures and environmental monitoring program, eliminating the use of high pressure hoses in the facility, conducting (b)(4) cleaning and sanitation, (b)(4) the production room floor, replacing worn and damaged equipment, retraining employees, instituting the use of new cleaning and sanitizing compounds, and revising traffic patterns and limiting access into your production areas. We will verify the adequacy of your implemented corrective actions during your next inspection.
Current Good Manufacturing Practice (21 CFR 117, Subpart B)
You did not maintain your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically, on September 21, 2021, the following facility conditions were observed:
A. The floor throughout the processing and staging area had cracks (0.1- 0.5 inches deep and 1 – 6 inches long), which were too numerous to count, and pits, too numerous to count. These areas can harbor microorganisms and make it difficult to ensure proper cleaning and sanitizing.
B. The wall and floor junctions throughout the processing and storage areas were observed to be damaged and crumbling. These areas can harbor microorganisms and make it difficult to ensure proper cleaning and sanitizing.
C. The floor drain in the processing room under the east side processing sink had an estimated 2 inches of standing water. A slow draining floor drain is an indication of improper cleaning frequency. In addition, standing water can harbor microorganisms.
D. Freezers (b)(4) and (b)(4) had significant build-up of ice on the ceiling, floors, and entryway. Ice buildup is an indication that the units are improperly working and can lead to temperature abuse.
Your responses dated November 1, 9 and 17, 2021, detail the corrective actions you have taken to address the insanitary facility conditions observed during the inspection. You state that you have (b)(4) the production room floor, replaced worn and damaged equipment, removed the ice build-up in the freezer, and conducted a (b)(4) cleaning. We will verify the adequacy of your implemented corrective actions during your next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of 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 all requirements of federal law, including FDA regulations. You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the above violations, we offer the following comment regarding your sanitation standard operating procedures (SSOPs). Your SSOP for “Production Pre-Operation” states that “before (b)(4) the supervisor or manager on duty will . . . [v]isually inspect the processing area and certify that it is clean, sanitized and ready for use.” It also provides that “Sanitizer dip solutions will be tested for proper strength and distributed to each workstation” and “will be changed as often as necessary to assure effectiveness.” Also, your SSOP for “Production Post-Operation Procedures” states that “At the end of (b)(4) . . . “[t]he supervisor or manager on duty will inspect the processing area to certify that it is clean and ready for use (b)(4). Any deficiencies will be addressed immediately and corrected.” However, the observations above indicate that these SSOPs were not properly implemented.
Please notify this office in writing within fifteen (15) business days of receipt of this letter of the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen (15) business days, state the reason for the delay and the time within which you will do so.
Please send your reply to the Food and Drug Administration, Attention: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at firstname.lastname@example.org. You may reach Ms. Potter at (303)236-3094 or the email address provided if you have questions regarding this matter.
E. Mark Harris
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Food Operations
Division West 4