"FDA laboratory analyses found the presence of the outbreak strain of S. Litchfield and two additional Salmonella strains, Salmonella Mbandaka (S. Mbandaka) and Salmonella Oranienburg (S. Oranienburg), which are human pathogens, in [the] facility. On October 20, 2022, [the] firm recalled various types of fresh fish processed at [the] facility and distributed between June 14, 2022 and October 17, 2022, because they had the potential of being contaminated with Salmonella. FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and whole genome sequencing (WGS) matches between clinical and FDA environmental samples, that fresh salmon processed at [the] facility was the likely source of this multistate S. Litchfield outbreak"
Salmonella was found throughout the facility, which indicates poor sanitation among other poor practices. Even though this is raw fish, Salmonella should not be present.
WARNING LETTER
Mariscos Bahia, Inc.
MARCS-CMS 646401 — FEBRUARY 07, 2023
"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."https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mariscos-bahia-inc-646401-02072023
WARNING LETTER
Mariscos Bahia, Inc.
MARCS-CMS 646401 — FEBRUARY 07, 2023
Recipient:
Hector M. Canino
Owner
Mariscos Bahia, Inc.
8300 Rex Rd.
Pico Rivera, CA 90660-3719
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
WL 646401
Dear Mr. Canino:
The United States Food and Drug Administration (FDA) and the California Department of Public Health (CDPH) inspected your seafood processing facility, Mariscos Bahia Inc, located at 8300 Rex Rd., Pico Rivera, CA 90660-3719 from October 6 to October 21, 2022. The inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Litchfield (S. Litchfield) infections linked to seafood, including fresh, raw salmon, supplied by your facility. According to the Centers for Disease Control and Prevention (CDC), 39 people from 4 states were infected with the outbreak strain of S. Litchfield. 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. Litchfield and two additional Salmonella strains, Salmonella Mbandaka (S. Mbandaka) and Salmonella Oranienburg (S. Oranienburg), which are human pathogens, in your facility. On October 20, 2022, your firm recalled various types of fresh fish processed at your facility and distributed between June 14, 2022 and October 17, 2022, because they had the potential of being contaminated with Salmonella. FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and whole genome sequencing (WGS) matches between clinical and FDA environmental samples, that fresh salmon processed at your facility was the likely source of this multistate S. Litchfield outbreak.
During the inspection of your facility, 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 fresh salmon and other fresh seafood processed by your firm are adulterated within the meaning of section 402(a)(4) of the Act, 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.External Link Disclaimer
At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA 483), Inspectional Observations, listing the deviations found at your facility. We received your email responses on October 18 and 21, 2022, and November 14 and 21, 2022. Further, you voluntarily suspended seafood processing while you implemented corrective actions. We have addressed the details of your response in the letter below.
Multistate Outbreak of Salmonella Lichfield linked to Fresh Raw Salmon
The FDA, along with CDC and state and local partners, investigated this multistate outbreak of S. Litchfield infections linked to fresh, raw salmon processed by Mariscos Bahia, Inc. This investigation included 39 ill people in 4 states who were infected with the outbreak strain, S. Litchfield. The last illness onset was October 23, 2022. WGS analysis was performed on Salmonella bacteria from the 39 ill people and showed that the Salmonella were closely related genetically to one another, indicating that ill people became sick from consuming the same food. Fifteen hospitalizations and no deaths were reported.
State and local public health officials interviewed people about the foods they ate in the week before they became ill. Of the 18 people interviewed, 13 (72%) reported eating raw fish, sushi, or poke. This percentage was significantly higher than the 7.9% of respondents who reported eating raw fish in the FoodNet Population Survey—a survey that helps estimate how often people eat various foods linked to diarrheal illness. This difference suggests that people in this outbreak got sick from eating raw fish. Of 12 people who remembered details of their meal, 10 (83%) reported raw salmon. Several ill people in the outbreak were identified as a part of three illness clusters at restaurants. A retail illness cluster is defined as two or more people who do not live in the same household who report eating food from the same retail location before getting sick. If several unrelated ill people ate food from the same retail location, it suggests that the contaminated food item was served or sold there. FDA’s investigation traced the source of fresh, raw salmon eaten by people in these three illness clusters back to Mariscos Bahia, Inc.
On October 6, 2022, FDA collected samples (environmental swabs) of your production environment. FDA analysis of sample INV 1173791 confirmed that 18 swabs were positive for S. Litchfield, S. Mbandaka, and/or S. Oranienburg.
WGS analysis was conducted for the above referenced S. Litchfield, S. Mbandaka, and S. Oranienburg isolates and determined that the S. Litchfield environmental isolates (Swab #6) matched the 39 clinical isolates that are from the 2022 S. Litchfield outbreak referenced above. S. Mbandaka was isolated in 17 swabs throughout your seafood processing environment. These isolates match each other and have an inconclusive relationship to a feed isolate from Germany and 20 clinical isolates from the U.S., Germany, and U.K. Additionally, S. Oranienburg was isolated from 1 swab (swab #94 was found to have both S. Mbandaka and S. Oranienburg) in your processing facility. It has an inconclusive relationship with 1 clinical isolate. We advised you of the importance of these WGS results via conference calls on October 17 and 19, 2022. During both calls, FDA provided detailed examples of corrective actions your firm could implement in response to the findings.
Based on the epidemiologic, traceback, and laboratory data, fresh salmon processed by Mariscos Bahia Inc are the likely source of this outbreak of S. Litchfield infections.
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. Consuming foods contaminated with Salmonella can lead to symptoms that 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.
The presence of Salmonella 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. 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. Although you may intend that your fresh salmon be cooked by the end-user, the outbreak investigation found that many of your customers served your fresh salmon raw. You are required to control the pathogenic hazard of Salmonella in your facility so that the food you produce is not adulterated and does not cause foodborne illness. Your control strategy of placing a statement on your invoices that instructs your customers to freeze your fresh fish products will not control pathogenic bacteria such as Salmonella. Rather, freezing at appropriate temperatures can be used as a control for parasites.
Your responses outline the corrective actions you have taken in response to the S. Litchfield outbreak and provide your environmental sample findings. On October 14, 2022, after the initial notification of the environmental sampling results, you voluntarily ceased processing seafood at your facility to conduct cleaning, sanitizing, and environmental vector sampling for Salmonella, including hiring a professional cleaning and sanitizing company that conducted a deep clean. On October 20, 2022, you initiated a voluntary recall of all seafood products processed and distributed by your firm between June 14, 2022 and October 17, 2022. On October 21, 2022, you contracted with third-party to conduct environmental sampling for Salmonella and facilitated a root-cause investigation. Thus far, you have provided results for swabs collected on October 19, 2022 from 30 sites and on October 22, 2022 from 99 sites; the results of which were negative for Salmonella and shared with the Agency on October 21 and 24, 2022, respectively. On October 25, 2022, you notified FDA that you had resumed processing fresh fish.
We received your completed root-cause analysis (RCA) on November 21, 2022. Your RCA states that the primary cause of the outbreak was restaurants serving raw or uncooked fish that was possibly contaminated with Salmonella, and the root-cause was cross contamination from wood pallets harboring pathogens and poor sanitation practices due to sanitation SOPs not being performed in an adequate manner. However, your RCA did not consider or eliminate all other potential sources and failed to address the basis for their elimination.
Additional corrective actions as part of an expanded RCA could include: an assessment of current sanitation monitoring procedures; a review of cleaning and sanitizing chemicals and procedures; an evaluation of controls for cross contamination and adulteration opportunities; review of sanitation monitoring records; evaluating existing employee health controls and their implementation; evaluating the effectiveness of existing environmental monitoring programs; reviewing traffic patterns and equipment layout; evaluating supplier’s seafood processing, growing conditions and harvesting practices; investigating water treatment, ice-making, and plumbing within the facility; investigating sanitation controls for outside sources of water and ice; reviewing responses to identified problems or inadequacies; and reviewing records and written procedures. Training records for employees on any new processes or procedures you implemented would be helpful in our future assessment of your RCA.
To date, you have not provided revised SSOPs and sanitation monitoring records even though you determined that improper implementation of your sanitation SOPs was a root cause of the contamination. We recommend that you develop comprehensive sanitation control procedures and increase the frequency of sanitation monitoring. Your corrective actions should provide details on the controls implemented to prevent cross-contamination.
Your response does not provide sufficient evidence to demonstrate that you have identified and corrected the cause of the insanitary conditions and practices in your processing environment to prevent the contamination of RTE fresh seafood that you may manufacture in the future. We recommend you consider taking additional corrective actions to address all likely or potential sources and routes of contamination during processing identified in your root cause investigation, such as creating an environmental monitoring plan (EMP) for extensive and robust routine environmental sampling for pathogens, including Salmonella and Listeria monocytogenes, since your firm is processing RTE fish, such as fresh salmon, that is distributed to sushi restaurants and consumed raw. To date, we have not received your revised EMP.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms and contamination of food, as required by 21 CFR 117.80(c)(2). Specifically, during the inspection, environmental sample INV1173791 was collected from your facility. Of (b)(4) swabs taken, Salmonella species were detected in 18 swabs collected from your (b)(4) square foot processing room as follows:
a) Swab (b)(4): Top of wooden pallet on floor at bottom of first shelving unit closest to employee entrance. Tubs of oysters were observed being held on this pallet. Pallets are interchangeable and can be used to hold multiple types of products including salmon.
b) Swab (b)(4): Top back of mobile trash can. A sanitation worker was observed picking up boxes from the floor, opening the lid, and discarding them in this trash can.
c) Swab (b)(4): Pallet jack #5 front wheel. This floor jack is moved in and out of the production room. It is used for wooden pallets containing boxes having either raw material or finished products.
d) Swab (b)(4): Worn cement at side of floor drain across from Table 1. Interchangeable pallets holding boxes containing raw material salmon were observed approximately 3 feet from this drain. The boxes are reused for packing finished salmon product.
e) Swab (b)(4): Foot post at right exit of (b)(4) portioning machine. Raw cut salmon is conveyed through the machine attached to the floor post. Workers were observed handling salmon portions coming off the conveyor of the (b)(4) machine.
f) Swab (b)(4): Drain screen in front of (b)(4) portioning machine. Interchangeable pallets holding boxes containing raw material salmon were observed approximately 1 foot from this drain. The boxes are reused for packing finished salmon product.
g) Swab (b)(4): Stainless steel portion at left of entrance of salmon skinning machine. Workers were observed hand-feeding raw salmon through this machine.
h) Swab (b)(4): (b)(4) lining at inside of salmon by-product bin. Salmon remnants cut from Table 4 (e.g., head, tail, and spine) are (b)(4) placed into this bin.
i) Swab (b)(4): (b)(4) hose between salmon disposal bin and Table 4. This washdown hose is used by workers to rinse salmon prior to processing. A production worker (b)(4). The spray nozzle of this hose was observed resting on the processing room floor during post-op sanitation on October 7, 2022.
j) Swab (b)(4): Bottom left shelf of Table 5. Ice from salmon boxes may fall onto this bottom shelf as the boxes are emptied. Two employees turn the receiving containers upside down, depositing whole fish with ice on the top part of the table.
k) Swab (b)(4): Leg of Table 6 furthest from wall, on the left. This table is dedicated for fish other than salmon. Halibut to be processed on this table was observed defrosting on a (b)(4) cart near the employee entrance.
l) Swab (b)(4): Top of wooden pallet observed approximately 1/2 foot away from Table 6. A box of black cod was observed directly on the pallet with a salmon box above it.
m) Swab (b)(4): Top of middle shelf at rack nearest Table 6. This is the (b)(4) Rack that holds salmon and non-salmon product. Remaining pallet boxes, or semi-processed product from the previous day’s production, may be placed on it.
n) Swab (b)(4): Foot of front right post of the (b)(4) Rack. An interchangeable pallet holding black cod was observed up against this post.
o) Swab (b)(4): (b)(4) wooden pallet holding (b)(4) boxes observed being held across from the sinks. Pallet is interchangeable for multiple types of products. “(b)(4)” brand salmon boxes were observed on the pallet.
p) Swab (b)(4): (b)(4) wooden pallet holding (b)(4) boxes immediately adjacent to the blue pallet. "(b)(4)" brand salmon boxes were observed on this pallet.
q) Swab (b)(4): (b)(4) wooden pallet holding (b)(4) boxes adjacent to pallet from which Sub #95 was collected. “(b)(4)” and “(b)(4)” brand salmon boxes were observed on this pallet.
r) Swab (b)(4): Wooden pallet holding (b)(4) boxes next to right post at product entrance. Pallet is interchangeable for multiple types of products. “(b)(4)” brand salmon boxes were observed on this pallet.
Although you provided documentation of corrective actions, including (b)(4) deep cleans of your processing facility and equipment and negative results from environmental testing, your responses did not fully address this observation. As stated previously, your root-cause investigation did not include details showing you considered and eliminated all potential sources of contamination to ensure future product is not contaminated.
Seafood HACCP
2. You must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with current good manufacturing practice requirements in 21 CFR Part 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). However, you failed to monitor persons working in direct contact with food, food-contact surfaces and food-packaging materials with sufficient frequency to ensure that such persons took necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.10(b)(9). This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product, 21 CFR § 123.11 (b)(8). Specifically, on October 7, 2022, at least (b)(4) production workers were observed using a high-pressure hose to rinse off their smocks and boots. The blast of water from this spray was observed hitting the floor at times and creating an aerosol which surrounded salmon fillets at least five feet away being packed in (b)(4) labeled "(b)(4), Lot (b)(4)." Further, your Sanitation Program dated 11/24/2020 and collected during the inspection states that high-pressure hoses should not be used.
Your response to the 483 violations received on November 14, 2022, did not address this observation. Additionally, during the inspection closeout on October 21, 2022, our investigators advised you that your firm’s SSOPs should be revised to address monitoring for the eight key areas of sanitation to be in compliance with 21 CFR 123.11. Your response to this warning letter should include details on how you intend to monitor for proper implementation of your sanitation procedures, employee training records, and include your current sanitation monitoring records for at least five days to demonstrate compliance with 21 CFR 123.11(b).
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for (b)(4) Salmon lists a monitoring procedure and frequency at the critical control point that is not adequate to control the food safety hazard of pathogenic growth and toxin formation. Specifically, your firm’s HACCP plan lists a monitoring procedure of "Visual check of cooler thermometer and temperature readings (b)(4)" at a frequency of (b)(4) during operation” at the “Cooler Storage” critical control point, and “Visual check of cooler thermometer and temperature readings (b)(4)” at a frequency of “Temperature check (b)(4)” at the “Cooler Storage(Finished Product)” critical control point. Your monitoring procedure and frequency do not ensure that product is continuously held at temperatures below (b)(4), with continuous temperature monitoring, including during the evening or on weekends. This is a repeat observation from previous inspections conducted in January of 2020 and June of 2017.
Your response received on November 14, 2022, provided a revised HACCP plan, dated November 9, 2022, that lists monitoring procedures of “Visual check of cooler/freezer thermometer and temperature readings (b)(4)” at a frequency of “(b)(4)” at the “Storage” critical control point and “Visual check of cooler thermometer and temperature readings (b)(4)” at a (b)(4)” at the “Storage (Finished Product)” critical control point that are not adequate to ensure the critical limit is met. To ensure that an adequate temperature is maintained, your monitoring procedure should indicate the use of a continuous temperature monitoring device with a visual check of the recorded data at least once per day of operation.
4. Your HACCP plan does not list the food safety hazards that are reasonably likely to occur, as required by 123.6(c)(1). Specifically, your HACCP plan for (b)(4) Salmon does not identify the following hazards:
a) Pathogenic bacteria growth and toxin formation
b) Undeclared allergens
Your response received on November 14, 2022, provided a revised HACCP plan, dated November 9, 2022, and lists a critical limit of “Product temperature must be (b)(4) or below” at a frequency of “Upon receiving every pallet of each shipment” that is not adequate to control for pathogenic growth and toxin formation at the “Receiving” critical control point because it does not ensure that the fish is maintained at (b)(4) or below throughout transit. For fish received under refrigeration, the monitoring procedure should include continuous temperature monitoring of the ambient temperature of the truck throughout transit. Also, these continuous temperature recording records should be obtained, maintained and reviewed to ensure transit temperatures were maintained at (b)(4) or below.
Additionally, your revised HACCP plan, lists a critical limit of “Identify fish by market name” by a “visual check” of the label at a frequency of “(b)(4)” that is not adequate to control for the hazard of undeclared allergens at the “Finished Product Labeling” step. We recommend that your monitoring procedure state that you will check that the finished product labeling includes the appropriate market name of the fish by visually comparing the label against the product specifications or invoice for accuracy at the start of the production lot and at least every two hours or when the labels are changed.
Your response to this warning letter should include a revised HACCP plan as described above along with critical control point monitoring records from five days or five batches to demonstrate proper implementation.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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 adequately 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.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
or emailed to ORAHAFWEST5FirmResponses@fda.hhs.gov.
Refer to the Unique Identification Number CMS 646401 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations- West Division 5
cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435
Hector M. Canino
Owner
Mariscos Bahia, Inc.
8300 Rex Rd.
Pico Rivera, CA 90660-3719
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
WL 646401
Dear Mr. Canino:
The United States Food and Drug Administration (FDA) and the California Department of Public Health (CDPH) inspected your seafood processing facility, Mariscos Bahia Inc, located at 8300 Rex Rd., Pico Rivera, CA 90660-3719 from October 6 to October 21, 2022. The inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Litchfield (S. Litchfield) infections linked to seafood, including fresh, raw salmon, supplied by your facility. According to the Centers for Disease Control and Prevention (CDC), 39 people from 4 states were infected with the outbreak strain of S. Litchfield. 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. Litchfield and two additional Salmonella strains, Salmonella Mbandaka (S. Mbandaka) and Salmonella Oranienburg (S. Oranienburg), which are human pathogens, in your facility. On October 20, 2022, your firm recalled various types of fresh fish processed at your facility and distributed between June 14, 2022 and October 17, 2022, because they had the potential of being contaminated with Salmonella. FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and whole genome sequencing (WGS) matches between clinical and FDA environmental samples, that fresh salmon processed at your facility was the likely source of this multistate S. Litchfield outbreak.
During the inspection of your facility, 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 fresh salmon and other fresh seafood processed by your firm are adulterated within the meaning of section 402(a)(4) of the Act, 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.External Link Disclaimer
At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA 483), Inspectional Observations, listing the deviations found at your facility. We received your email responses on October 18 and 21, 2022, and November 14 and 21, 2022. Further, you voluntarily suspended seafood processing while you implemented corrective actions. We have addressed the details of your response in the letter below.
Multistate Outbreak of Salmonella Lichfield linked to Fresh Raw Salmon
The FDA, along with CDC and state and local partners, investigated this multistate outbreak of S. Litchfield infections linked to fresh, raw salmon processed by Mariscos Bahia, Inc. This investigation included 39 ill people in 4 states who were infected with the outbreak strain, S. Litchfield. The last illness onset was October 23, 2022. WGS analysis was performed on Salmonella bacteria from the 39 ill people and showed that the Salmonella were closely related genetically to one another, indicating that ill people became sick from consuming the same food. Fifteen hospitalizations and no deaths were reported.
State and local public health officials interviewed people about the foods they ate in the week before they became ill. Of the 18 people interviewed, 13 (72%) reported eating raw fish, sushi, or poke. This percentage was significantly higher than the 7.9% of respondents who reported eating raw fish in the FoodNet Population Survey—a survey that helps estimate how often people eat various foods linked to diarrheal illness. This difference suggests that people in this outbreak got sick from eating raw fish. Of 12 people who remembered details of their meal, 10 (83%) reported raw salmon. Several ill people in the outbreak were identified as a part of three illness clusters at restaurants. A retail illness cluster is defined as two or more people who do not live in the same household who report eating food from the same retail location before getting sick. If several unrelated ill people ate food from the same retail location, it suggests that the contaminated food item was served or sold there. FDA’s investigation traced the source of fresh, raw salmon eaten by people in these three illness clusters back to Mariscos Bahia, Inc.
On October 6, 2022, FDA collected samples (environmental swabs) of your production environment. FDA analysis of sample INV 1173791 confirmed that 18 swabs were positive for S. Litchfield, S. Mbandaka, and/or S. Oranienburg.
WGS analysis was conducted for the above referenced S. Litchfield, S. Mbandaka, and S. Oranienburg isolates and determined that the S. Litchfield environmental isolates (Swab #6) matched the 39 clinical isolates that are from the 2022 S. Litchfield outbreak referenced above. S. Mbandaka was isolated in 17 swabs throughout your seafood processing environment. These isolates match each other and have an inconclusive relationship to a feed isolate from Germany and 20 clinical isolates from the U.S., Germany, and U.K. Additionally, S. Oranienburg was isolated from 1 swab (swab #94 was found to have both S. Mbandaka and S. Oranienburg) in your processing facility. It has an inconclusive relationship with 1 clinical isolate. We advised you of the importance of these WGS results via conference calls on October 17 and 19, 2022. During both calls, FDA provided detailed examples of corrective actions your firm could implement in response to the findings.
Based on the epidemiologic, traceback, and laboratory data, fresh salmon processed by Mariscos Bahia Inc are the likely source of this outbreak of S. Litchfield infections.
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. Consuming foods contaminated with Salmonella can lead to symptoms that 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.
The presence of Salmonella 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. 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. Although you may intend that your fresh salmon be cooked by the end-user, the outbreak investigation found that many of your customers served your fresh salmon raw. You are required to control the pathogenic hazard of Salmonella in your facility so that the food you produce is not adulterated and does not cause foodborne illness. Your control strategy of placing a statement on your invoices that instructs your customers to freeze your fresh fish products will not control pathogenic bacteria such as Salmonella. Rather, freezing at appropriate temperatures can be used as a control for parasites.
Your responses outline the corrective actions you have taken in response to the S. Litchfield outbreak and provide your environmental sample findings. On October 14, 2022, after the initial notification of the environmental sampling results, you voluntarily ceased processing seafood at your facility to conduct cleaning, sanitizing, and environmental vector sampling for Salmonella, including hiring a professional cleaning and sanitizing company that conducted a deep clean. On October 20, 2022, you initiated a voluntary recall of all seafood products processed and distributed by your firm between June 14, 2022 and October 17, 2022. On October 21, 2022, you contracted with third-party to conduct environmental sampling for Salmonella and facilitated a root-cause investigation. Thus far, you have provided results for swabs collected on October 19, 2022 from 30 sites and on October 22, 2022 from 99 sites; the results of which were negative for Salmonella and shared with the Agency on October 21 and 24, 2022, respectively. On October 25, 2022, you notified FDA that you had resumed processing fresh fish.
We received your completed root-cause analysis (RCA) on November 21, 2022. Your RCA states that the primary cause of the outbreak was restaurants serving raw or uncooked fish that was possibly contaminated with Salmonella, and the root-cause was cross contamination from wood pallets harboring pathogens and poor sanitation practices due to sanitation SOPs not being performed in an adequate manner. However, your RCA did not consider or eliminate all other potential sources and failed to address the basis for their elimination.
Additional corrective actions as part of an expanded RCA could include: an assessment of current sanitation monitoring procedures; a review of cleaning and sanitizing chemicals and procedures; an evaluation of controls for cross contamination and adulteration opportunities; review of sanitation monitoring records; evaluating existing employee health controls and their implementation; evaluating the effectiveness of existing environmental monitoring programs; reviewing traffic patterns and equipment layout; evaluating supplier’s seafood processing, growing conditions and harvesting practices; investigating water treatment, ice-making, and plumbing within the facility; investigating sanitation controls for outside sources of water and ice; reviewing responses to identified problems or inadequacies; and reviewing records and written procedures. Training records for employees on any new processes or procedures you implemented would be helpful in our future assessment of your RCA.
To date, you have not provided revised SSOPs and sanitation monitoring records even though you determined that improper implementation of your sanitation SOPs was a root cause of the contamination. We recommend that you develop comprehensive sanitation control procedures and increase the frequency of sanitation monitoring. Your corrective actions should provide details on the controls implemented to prevent cross-contamination.
Your response does not provide sufficient evidence to demonstrate that you have identified and corrected the cause of the insanitary conditions and practices in your processing environment to prevent the contamination of RTE fresh seafood that you may manufacture in the future. We recommend you consider taking additional corrective actions to address all likely or potential sources and routes of contamination during processing identified in your root cause investigation, such as creating an environmental monitoring plan (EMP) for extensive and robust routine environmental sampling for pathogens, including Salmonella and Listeria monocytogenes, since your firm is processing RTE fish, such as fresh salmon, that is distributed to sushi restaurants and consumed raw. To date, we have not received your revised EMP.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms and contamination of food, as required by 21 CFR 117.80(c)(2). Specifically, during the inspection, environmental sample INV1173791 was collected from your facility. Of (b)(4) swabs taken, Salmonella species were detected in 18 swabs collected from your (b)(4) square foot processing room as follows:
a) Swab (b)(4): Top of wooden pallet on floor at bottom of first shelving unit closest to employee entrance. Tubs of oysters were observed being held on this pallet. Pallets are interchangeable and can be used to hold multiple types of products including salmon.
b) Swab (b)(4): Top back of mobile trash can. A sanitation worker was observed picking up boxes from the floor, opening the lid, and discarding them in this trash can.
c) Swab (b)(4): Pallet jack #5 front wheel. This floor jack is moved in and out of the production room. It is used for wooden pallets containing boxes having either raw material or finished products.
d) Swab (b)(4): Worn cement at side of floor drain across from Table 1. Interchangeable pallets holding boxes containing raw material salmon were observed approximately 3 feet from this drain. The boxes are reused for packing finished salmon product.
e) Swab (b)(4): Foot post at right exit of (b)(4) portioning machine. Raw cut salmon is conveyed through the machine attached to the floor post. Workers were observed handling salmon portions coming off the conveyor of the (b)(4) machine.
f) Swab (b)(4): Drain screen in front of (b)(4) portioning machine. Interchangeable pallets holding boxes containing raw material salmon were observed approximately 1 foot from this drain. The boxes are reused for packing finished salmon product.
g) Swab (b)(4): Stainless steel portion at left of entrance of salmon skinning machine. Workers were observed hand-feeding raw salmon through this machine.
h) Swab (b)(4): (b)(4) lining at inside of salmon by-product bin. Salmon remnants cut from Table 4 (e.g., head, tail, and spine) are (b)(4) placed into this bin.
i) Swab (b)(4): (b)(4) hose between salmon disposal bin and Table 4. This washdown hose is used by workers to rinse salmon prior to processing. A production worker (b)(4). The spray nozzle of this hose was observed resting on the processing room floor during post-op sanitation on October 7, 2022.
j) Swab (b)(4): Bottom left shelf of Table 5. Ice from salmon boxes may fall onto this bottom shelf as the boxes are emptied. Two employees turn the receiving containers upside down, depositing whole fish with ice on the top part of the table.
k) Swab (b)(4): Leg of Table 6 furthest from wall, on the left. This table is dedicated for fish other than salmon. Halibut to be processed on this table was observed defrosting on a (b)(4) cart near the employee entrance.
l) Swab (b)(4): Top of wooden pallet observed approximately 1/2 foot away from Table 6. A box of black cod was observed directly on the pallet with a salmon box above it.
m) Swab (b)(4): Top of middle shelf at rack nearest Table 6. This is the (b)(4) Rack that holds salmon and non-salmon product. Remaining pallet boxes, or semi-processed product from the previous day’s production, may be placed on it.
n) Swab (b)(4): Foot of front right post of the (b)(4) Rack. An interchangeable pallet holding black cod was observed up against this post.
o) Swab (b)(4): (b)(4) wooden pallet holding (b)(4) boxes observed being held across from the sinks. Pallet is interchangeable for multiple types of products. “(b)(4)” brand salmon boxes were observed on the pallet.
p) Swab (b)(4): (b)(4) wooden pallet holding (b)(4) boxes immediately adjacent to the blue pallet. "(b)(4)" brand salmon boxes were observed on this pallet.
q) Swab (b)(4): (b)(4) wooden pallet holding (b)(4) boxes adjacent to pallet from which Sub #95 was collected. “(b)(4)” and “(b)(4)” brand salmon boxes were observed on this pallet.
r) Swab (b)(4): Wooden pallet holding (b)(4) boxes next to right post at product entrance. Pallet is interchangeable for multiple types of products. “(b)(4)” brand salmon boxes were observed on this pallet.
Although you provided documentation of corrective actions, including (b)(4) deep cleans of your processing facility and equipment and negative results from environmental testing, your responses did not fully address this observation. As stated previously, your root-cause investigation did not include details showing you considered and eliminated all potential sources of contamination to ensure future product is not contaminated.
Seafood HACCP
2. You must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with current good manufacturing practice requirements in 21 CFR Part 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). However, you failed to monitor persons working in direct contact with food, food-contact surfaces and food-packaging materials with sufficient frequency to ensure that such persons took necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.10(b)(9). This is related to the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product, 21 CFR § 123.11 (b)(8). Specifically, on October 7, 2022, at least (b)(4) production workers were observed using a high-pressure hose to rinse off their smocks and boots. The blast of water from this spray was observed hitting the floor at times and creating an aerosol which surrounded salmon fillets at least five feet away being packed in (b)(4) labeled "(b)(4), Lot (b)(4)." Further, your Sanitation Program dated 11/24/2020 and collected during the inspection states that high-pressure hoses should not be used.
Your response to the 483 violations received on November 14, 2022, did not address this observation. Additionally, during the inspection closeout on October 21, 2022, our investigators advised you that your firm’s SSOPs should be revised to address monitoring for the eight key areas of sanitation to be in compliance with 21 CFR 123.11. Your response to this warning letter should include details on how you intend to monitor for proper implementation of your sanitation procedures, employee training records, and include your current sanitation monitoring records for at least five days to demonstrate compliance with 21 CFR 123.11(b).
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for (b)(4) Salmon lists a monitoring procedure and frequency at the critical control point that is not adequate to control the food safety hazard of pathogenic growth and toxin formation. Specifically, your firm’s HACCP plan lists a monitoring procedure of "Visual check of cooler thermometer and temperature readings (b)(4)" at a frequency of (b)(4) during operation” at the “Cooler Storage” critical control point, and “Visual check of cooler thermometer and temperature readings (b)(4)” at a frequency of “Temperature check (b)(4)” at the “Cooler Storage(Finished Product)” critical control point. Your monitoring procedure and frequency do not ensure that product is continuously held at temperatures below (b)(4), with continuous temperature monitoring, including during the evening or on weekends. This is a repeat observation from previous inspections conducted in January of 2020 and June of 2017.
Your response received on November 14, 2022, provided a revised HACCP plan, dated November 9, 2022, that lists monitoring procedures of “Visual check of cooler/freezer thermometer and temperature readings (b)(4)” at a frequency of “(b)(4)” at the “Storage” critical control point and “Visual check of cooler thermometer and temperature readings (b)(4)” at a (b)(4)” at the “Storage (Finished Product)” critical control point that are not adequate to ensure the critical limit is met. To ensure that an adequate temperature is maintained, your monitoring procedure should indicate the use of a continuous temperature monitoring device with a visual check of the recorded data at least once per day of operation.
4. Your HACCP plan does not list the food safety hazards that are reasonably likely to occur, as required by 123.6(c)(1). Specifically, your HACCP plan for (b)(4) Salmon does not identify the following hazards:
a) Pathogenic bacteria growth and toxin formation
b) Undeclared allergens
Your response received on November 14, 2022, provided a revised HACCP plan, dated November 9, 2022, and lists a critical limit of “Product temperature must be (b)(4) or below” at a frequency of “Upon receiving every pallet of each shipment” that is not adequate to control for pathogenic growth and toxin formation at the “Receiving” critical control point because it does not ensure that the fish is maintained at (b)(4) or below throughout transit. For fish received under refrigeration, the monitoring procedure should include continuous temperature monitoring of the ambient temperature of the truck throughout transit. Also, these continuous temperature recording records should be obtained, maintained and reviewed to ensure transit temperatures were maintained at (b)(4) or below.
Additionally, your revised HACCP plan, lists a critical limit of “Identify fish by market name” by a “visual check” of the label at a frequency of “(b)(4)” that is not adequate to control for the hazard of undeclared allergens at the “Finished Product Labeling” step. We recommend that your monitoring procedure state that you will check that the finished product labeling includes the appropriate market name of the fish by visually comparing the label against the product specifications or invoice for accuracy at the start of the production lot and at least every two hours or when the labels are changed.
Your response to this warning letter should include a revised HACCP plan as described above along with critical control point monitoring records from five days or five batches to demonstrate proper implementation.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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 adequately 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.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
or emailed to ORAHAFWEST5FirmResponses@fda.hhs.gov.
Refer to the Unique Identification Number CMS 646401 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations- West Division 5
cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435
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