As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
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.
Wise Spice Catering Company
Hialeah, FL
A food firm in Florida is on notice from the FDA for violations of federal regulations in their facility, including the presence of Listeria monocytogenes and insects throughout the facility.
In a March 8 warning letter, the FDA described an April 19 through Aug. 1, 2022, inspection of Wise Spice Catering Company’s ready-to-eat (RTE) food facility in Hialeah, FL.
The FDA’s inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. These violations resulted in the issuance of an FDA Form 483. The significant violations are as follows:
Pathogen Findings
FDA’s inspection included the collection of environmental swabs which found that 19 swabs were confirmed positive for L. monocytogenes. Of the positive findings, one swab was collected from the food-contact surface of a prep table in the (redacted) Room used in the assembling of the firm’s RTE closed faced sandwiches, and one swab was collected from the food-contact surface of a black milk crate holding raw tomatoes and onion used in RTE closed faced sandwiches and salads. This was not the first time Listeria monocytogenes was found in environmental samples collected in their facilities building. In 2020, FDA detected Listeria monocytogenes in six environmental swabs; in 2018, FDA detected Listeria monocytogenes in nine environmental swabs; and in 2017 FDA detected Listeria monocytogenes in 18 environmental swabs.
On May 6, 2022, the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) notified FDA of one environmental sample collected from non-food contact surfaces at their facility which tested positive for Listeria monocytogenes. This was not the first time Listeria monocytogenes was found by USDA/FSIS in environmental samples collected in their facilities building. In 2015, USDA/FSIS also detected Listeria monocytogenes in one environmental sample.
Moreover, on May 31, 2022, the Florida Department of Agriculture and Consumer Services (FDACS) collected finished product samples of a Ham, Egg and Cheese Sandwich and a Beef, Beans Rice Cheese Burrito (contained (redacted) percent beef) which both tested positive for Listeria monocytogenes. On June 10, 2022, FDACS issued the firm a Stop Sales Order and Destruction for their sandwich products and issued a Stop Use Order on their (redacted) Preparation Room, preventing the use of this room in their manufacturing operation. This is not the first time FDACS has isolated Listeria monocytogenes from their finished products; in 2015 finished product samples of a Tuna Sandwich, Ham Sandwich, Midnight Regular Sandwich, Ham Wrap Sandwich, Deli Ham Sandwich, and Ham Omelet Sandwich tested positive for Listeria monocytogenes.
Whole genome sequencing (WGS) was conducted on the above referenced Listeria monocytogenes isolates obtained from the FDA environmental samples, USDA/FSIS environmental samples, and FDACS product samples. Based on the results of the WGS analysis, these isolates represent 18 different strains of Listeria monocytogenes. The WGS analysis identified multiple strains of Listeria monocytogenes isolated over multiple years which is indicative of the presence of resident pathogens or harborage sites in their facility. FDA advised the firm of the WGS results and its importance on June 21, 2022. Of the 18 identified strains, the following nine strains of are particular significance:
- One strain includes isolates from FDA environmental samples collected from their facility in 2022, 2020, 2018, and 2017, the May 31, 2022 FDACS product sample of Ham Egg Cheese Sandwich which was manufactured at their facility, an environment sample collected from non-food contact surfaces at their facility in 2022 by USDA/FSIS, and environmental samples collected from other firm(s) located in Florida.
- One strain includes an isolate from their Beef Beans Rice Cheese Burrito product sample collected by FDACS on May 31, 2022, which does not match any other food, environmental, or clinical isolates in the National Center for Biotechnology Information (NCBI) Pathogen Detection database.
- One strain includes isolates from FDA environmental samples collected from their facility in 2017 and a 2015 FDACS product sample of Tuna Sandwich which was manufactured at their facility.
- One strain includes isolates from an FDA environmental sample collected from their facility in 2017, a 2015 FDACS product sample of Ham Sandwich which was manufactured at their facility, an environment sample collected from non-food contact surfaces at their facility in 2015 by USDA/FSIS, an environmental sample collected from another of their sandwich manufacturing facilities (Charanga Catering, LLC located in Florida), and an environmental sample collected from one firm located in Florida.
- One strain includes isolates from FDA environmental samples collected from their facility in 2022, a 2015 FDACS product sample of Ham Omelet Sandwich which was manufactured at their facility, and environmental and product isolates collected from other firm(s) located in Florida.
- One strain includes isolates from FDA environmental samples collected from their facility in 2018 and 2017, a 2015 FDACS product sample of a Midnight Regular Sandwich which was manufactured at their facility, and environmental and product samples collected from other firm(s) located in Florida.
- One strain includes isolates from FDA environmental samples collected from their facility in 2017, 2015 FDACS product samples of a Deli Ham Sandwich and Ham Wrap Sandwich, which were manufactured at their facility, and environmental and product isolates collected from other firm(s) located in Florida.
- One strain includes isolates from FDA environmental samples collected from their facility in 2022 and 2020, four samples collected from ill people which were deposited in the public repository at the NCBI between 2014 and 2021, and UDSA/FSIS food and environmental isolates collected from firms located in Florida, Texas and New York. These findings demonstrate that this strain is known to cause human illness.
- One strain includes isolates from an FDA environmental sample collected from their facility in 2022, a sample collected from an ill person which was deposited in the public repository at the NBCI in 2016 and food samples collected by USDA Agricultural Research Service. These findings demonstrate that this strain is known to cause human illness.
The presence of Listeria monocytogenes in their facility and their products is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens in their facility to prevent contamination of food. Appropriate control of Listeria monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. FDA findings indicate that their firm is neither achieving satisfactory control against the presence of Listeria monocytogenes within their facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.
Given the history and current inspection findings, FDA continues to be concerned about their ability to maintain a sanitary environment. FDA recommend that they identify potential harborage sites and source(s) of the organism in their processing environment and implement the necessary methods and controls to ensure Listeria monocytogenes does not contaminate their environment or their RTE food products.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. The firm did not take effective measures to exclude pests from their packing and holding areas and to protect against the contamination of food on the premises by pests. Specifically, insect activity was observed throughout their facility including the following:
a. One live cockroach was observed on an empty brown plastic crate used to store and transport RTE packaged foods for customer orders, with crate directly next to stainless steel packaging tables in the front packaging/sales area.
b. Approximately eight live apparent cockroaches were observed moving between metal panel and wall, and on the floor next to large kettles used for meat and black beans next to the side exit door in the shared USDA-regulated kitchen area.
c. One apparent live German cockroach was observed crawling on the floor outside the FDA-regulated kitchen moving towards the wash room.
d. Apparent flies, too numerous to count, were observed throughout various processing areas of the facility including: the front packaging and sales area with flies landing on scales, equipment and packages of cooked ready-to-eat foods such as rice, beans, eggs, and fries; inside the kitchen during food preparation and packaging; and dry storage area.
e. Two apparent flies were observed landing on an uncovered metal tray of cooked yuca in the front sales and packaging area, prior to an employee moving the tray inside the walk-in cooler to be cooled.
f. A plastic tray with packages of rice, beans, and plantains was observed with apparent bird excreta in the front sales area.
2. The firm’s plant is not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food contact surfaces, or food packaging materials, as required. Specifically,
a. Condensation was observed on the underside of condensing unit located directly above stainless-steel processing table used to manufacture closed-face sandwiches; and was observed dripping onto surface of processing table, inside the (redacted) processing room.
b. Condensation was observed on the black pipe cover under condensing unit, directly above a storage rack used to store raw materials, dripping onto a cardboard box with margarine and onto the floor inside (redacted) #1.
3. The firm did not maintain their plant in a clean and sanitary condition, and they did not clean and sanitize their utensils or equipment in a manner that protects against contamination, as required. Specifically,
a. During FDA inspection investigators observed stagnant water on a number of occasions, including on the floor and around floor drains in the front sales and food preparation area, on the floor with cracks and patches under storage racks holding cooked rice; on missing patches of floor near condensing unit inside (redacted) #1 used to store RTE food products such as closed-faced sandwiches; and on missing patches of floor at entrance to the (redacted) room.
b. An employee preparing to make RTE closed face sandwiches used an unclean knife to cut open packages of cooked deli ham blocks. The employee brought the knife from the USDA-regulated processing side and did not clean or sanitize the knife prior to cutting. Additionally, the investigator observed the knife had orange dried food residue near the white handle.
4. The firm did not hold food that can support the rapid growth of undesirable microorganisms at temperatures that will prevent the food from being adulterated, as required. Specifically, the firm did not hold their RTE food products at adequate temperatures. FDA investigators observed RTE food products being held in their customer sales area under ambient conditions for an extended period of time.
Specifically,
a. FDA investigators observed that on April 21, 2022, from (redacted) to (redacted), their scrambled eggs with onion and peppers product was available for sale. FDA investigators measured their product temperature using an FDA calibrated thermometer, reporting that their scrambled eggs with onion and peppers product temperature was (redacted)°F (redacted) hours after its preparation.
b. FDA investigators observed that on April 21, 2022, from (redacted) to (redacted) their boiled cassava “yuca” product was available for sale. FDA investigators measured their product temperature using an FDA calibrated thermometer, reporting that their boiled cassava “yuca” product temperature was (redacted)°F (redacted) hours after its preparation.
The full warning letter can be viewed here.
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