April 3, 2023 CFSI Staff

Salmonella outbreak leads to FDA warning; another firm warned because of Listeria and insects

Mariscos Bahia, Inc.
Pico Rivera, CA

A food firm in California is on notice from the FDA for violations of various FDA regulations, including Salmonella in their seafood processing facility. Inspection of Mariscos Bahia Inc. was prompted by a Salmonella outbreak that was linked to fresh salmon processed at their facility.

In a Feb. 7, 2023, warning letter, the FDA described an Oct. 6-21, 2022, FDA and California Department of Public Health (CDPH) inspection of Mariscos Bahia Inc’s seafood processing facility in Pico Rivera, CA.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483.

The significant violations are as follows:

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 of Salmonella. The last illness onset was Oct. 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 reported eating raw fish, sushi, or poke. Of 12 people who remembered details of their meal, 10 reported raw salmon. Several ill people in the outbreak were identified as a part of three illness clusters at restaurants.

FDA’s investigation traced the source of fresh, raw salmon eaten by people in these three illness clusters back to Mariscos Bahia, Inc.

On Oct. 6, 2022, FDA collected samples of the firm’s production environment. FDA analysis confirmed that 18 swabs were positive for Salmonella Litchfield, Salmonella Mbandaka, and/or Salmonella Oranienburg.

Whole genome sequencing analysis was conducted for the Salmonella isolates and determined that the Salmonella Litchfield environmental isolates matched the 39 clinical isolates that were from the 2022 Salmonella Litchfield outbreak referenced above. Salmonella Mbandaka was isolated in 17 swabs throughout their 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, Salmonella Oranienburg was isolated from 1 swab (was found to have both Salmonella Mbandaka and Salmonella Oranienburg) in their processing facility. It has an inconclusive relationship with one clinical isolate. The FDA advised them of the importance of these WGS results via conference calls on Oct. 17 and 19, 2022. During both calls, FDA provided detailed examples of corrective actions their 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 the Salmonella 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.

The presence of Salmonella in the firm’s facility is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens in their 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 the firm may intend that their fresh salmon be cooked by the end-user, the outbreak investigation found that many of their customers served their fresh salmon raw. They are required to control the pathogenic hazard of Salmonella in their facility so that the food they produce is not adulterated and does not cause foodborne illness. The firm’s control strategy of placing a statement on their invoices that instructs their customers to freeze their fresh fish products will not control pathogenic bacteria such as Salmonella. Rather, freezing at appropriate temperatures can be used as a control for parasites.

The full warning letter can be viewed here.

View more here.

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