The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.

Discover Fresh Foods LLC
Greenville, SC

The FDA has warned a food firm in South Carolina over serious violations of federal regulations, including years of positive Listeria tests found by the FDA, USDA FSIS and Florida Department of Agriculture and Consumer Services (FDACS) in their ready-to-eat (RTE) manufacturing facility and products.

The firm manufactures refrigerated ready-to-eat (RTE) dips and spreads. During the FDA’s inspection of their facility, FDA investigations found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation. Additionally, the FDA collected environmental samples from various areas in their processing facility. FDA laboratory analysis of the environmental sample found the presence of Listeria monocytogenes, a human pathogen, in their facility.

In a June 26, 2024 warning letter, the FDA described a Dec. 11, 2023, through Jan. 22, 2024, inspection of Discover Fresh Foods, LLC’s food manufacturing facility in Easley, SC.

FDA’s inspection resulted in the issuance of an FDA-483, Inspectional Observations, listing deviations found during the inspection.

Some of the significant violations:

Hazard Analysis and Risk-based Preventive Controls:

The firm is required to identify and implement preventive controls adequate to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by their facility will not be adulterated or misbranded.

The firm’s facility manufactures RTE food products that are exposed to the environment prior packaging and after any pathogen lethal treatment, wher they may be contaminated with environmental pathogens such as Listeria monocytogenes. The firm’s packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation1 lethal to the pathogen) that would significantly minimize the pathogen. Their food safety plan “Sanitation Preventive Control Summary” for spreads, dips, salad dressing, and baked goods identifies two sanitation preventive controls: SaPC1 for the hazard of microbial contamination and SaPc2 for the hazard of Listeria spp. and lists monitoring, corrective actions, and verification procedures for controlling these hazards. However, they did not implement sanitation controls adequate to ensure that their facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of recontamination with environmental pathogens, as required, and as further discussed below.

Listeria monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities wher it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant wher this organism can grow and survive, and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with Listeria monocytogenes can lead to a severe, sometimes life-threatening, illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.

To date, no known clinical illnesses have been linked to the firm’s RTE dips and spreads. However, FDA laboratory analysis of environmental sample #1242488 collected on Dec. 13, 2023, found that three out of the 99 total environmental swabs were positive for Listeria monocytogenes. The positive swabs were recovered from non-food-contact surfaces in Production Room (redacted by FDA), and (redacted by FDA) during the production of Taste of the South Fried Pickle Dip, and the underside of the top level of the red cart in (redacted by FDA). FDA laboratory analysis of sample #1242488 also found three out of the 99 swabs were positive for Listeria innocua. These swabs were obtained from their (redacted by FDA) transfer pump bottom frame, trash bin wheel and bottom of sanitation squeegee.

During and prior to FDA inspection, the firm also manufactured RTE dips and spreads under the jurisdiction of USDA FSIS on shared equipment and at the same time as FDA-regulated product. USDA FSIS has previously detected Listeria monocytogenes in finished product and environmental samples collected in their facility in 2018 and 2023. USDA FSIS detected Listeria monocytogenes in Buffalo Style Chicken Dip in 2018 and 2023, and both products were destroyed. USDA FSIS also detected Listeria monocytogenes in six environmental swabs, including two isolates from food contact surfaces, the bottom of a chicken bucket and an employee apron in 2018 and 2023. In addition, the Florida Department of Agriculture and Consumer Services (FDACS) detected Listeria monocytogenes in a retail sample of their Chipotle Chicken Salad in 2017.

On Dec. 28, 2023, the FDA notified the company that it detected Listeria monocytogenes in three swabs from FDA Sample 1242488. After receiving the results, the firm released finished product manufactured on the day of the sample collection into interstate commerce because the positive swabs were collected from non-food-contact surfaces and no cross-contamination was observed between non-food-contact surfaces and finished product. The firm began an intensified cleaning process on Dec. 29, 2023, for the three areas that tested positive for Listeria monocytogenes. The firm collected (redacted by FDA) of environmental swabs on these surfaces during (redacted by FDA), and (redacted by FDA). They did not detect Listeria monocytogenes in their additional environmental samples.

Whole Genome Sequencing (WGS) analysis was conducted on the following Listeria monocytogenes isolates obtained from FDA, USDA FSIS and FDACS retail product sample, environmental and finished products samples, as follows:

• three Listeria monocytogenes isolates obtained from FDA environmental sample 124288 in 2023;
• four Listeria monocytogenes isolates obtained from USDA FSIS environmental samples in 2023;
• one Listeria monocytogenes isolate obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2023;
• two Listeria monocytogenes isolates obtained from USDA FSIS environmental samples in 2018;
• one Listeria monocytogenes isolates obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2018; and
• one Listeria monocytogenes isolate obtained from Chipotle Chicken Salad collected by FDACS in 2017.

based on the results of the WGS analysis, the 12 isolates represent a single strain of Listeria monocytogenes. The presence of the same strain of Listeria monocytogenes over multiple years indicates that there has been a resident pathogen in their facility since at least Nov. 2017. FDA advised them of these WGS results via conference calls on Jan. 10 and 17, 2024.

In addition, in Nov. 2023, the firm also isolated Listeria monocytogenes in 13 zone (redacted by FDA) and zone (redacted by FDA) environmental swabs and three finished product samples of burnt ends dip. They performed intensified cleaning and sanitizing of food-contact equipment and revised their (SSOPs). Subsequently, they destroyed finished products associated with food-contact surfaces positive for Listeria monocytogenes and finished product found to contain Listeria monocytogenes. They decommissioned and removed their (redacted by FDA) Chopper (redacted by FDA) from their facility on Nov. 17, 2023, which they suspected was the source of the pathogen.

The firm’s response dated Feb. 12, 2024, included a summary of their responses to the above-mentioned pathogen findings not limited to, retaining food safety counsel, removing equipment suspected as the source of harborage, expanding their sanitation staff, updating their SSOPs and utilizing stronger sanitizers, changing employee traffic flow and the movement of equipment throughout the facility, changing the facility’s sanitary design, increasing the quantity and frequency of environmental sampling, updating their employee Good Manufacturing Practices (GMPs), eliminating plastic pallets, and filling in unnecessary drains. In addition, they collected (redacted by FDA) environmental samples since Nov. 2023, which have all been followed by an intensified cleaning including QA observations (e.g., verification of cleaning), increased sanitizer concentration followed by (redacted by FDA) days of follow-up swabs during (redacted by FDA), and (redacted by FDA) production. They stated they have not found Listeria spp. during any retests of equipment. However, they detected Listeria spp. in two additional non-food-contact surfaces on Dec. 29, 2023, and on Jan. 3, 2024, on the floor in Production Room (redacted by FDA) and on the floor in the (redacted by FDA) room, respectively.

On Feb. 2, 2024, USDA FSIS notified FDA Listeria monocytogenes was detected in two additional environmental swabs collected from non-food-contact surfaces (e.g., cart wheels) at their facility. WGS analysis of the isolates indicates that one of the isolates represents the same strain of Listeria monocytogenes present since at least Nov. 2017, as mentioned above and one of the isolates represents a strain not previously identified in their facility.

Per the firm’s response dated Feb. 12, 2024, they made changes to their SSOPs for cleaning on a routine basis and after an environmental positive of equipment or the facility. They eliminated additional routes of pathogen recontamination in the processing area by restricting movement of equipment and utensils and employee traffic flow. They made sanitary design changes such as installing foot foamers at all entrances to the food processing area. In their updated response dated Feb. 23, 2024, they implemented a test and hold procedure for both FDA and USDA FSIS finished products and made additional changes to their SSOPs. Since that date, they reported they had not detected Listeria monocytogenes in any FDA finished product samples. As of March 11, 2024, the firm reported all finished product sample results were negative. However, they did detect Listeria spp. on the chassis of a mixing bowl in the Production Room (redacted by FDA) ((redacted by FDA)) and conducted intensified cleaning and swabbing. In addition, they completed floor replacement and/or repair throughout the processing area.

Despite their corrective actions, on March 18, 2024, USDA FSIS notified the firm they detected Listeria monocytogenes in Buffalo Style Chicken dip (finished packaged product) and environmental swabs collected from food-contact and non-food-contact surfaces on March 12, 2024. The Buffalo Style Chicken dip was not distributed. WGS analysis of the isolates indicate that the isolates represent the same strain of Listeria monocytogenes previously found in their facility since at least Nov. 2017. These findings demonstrated that their corrective actions had been inadequate to significantly minimize or prevent Listeria monocytogenes in their facility. FDA advised them of these WGS results via a conference call on April 5, 2024.

During the FDA call on April 5, 2024, the firm stated they believe the re-installation of the remediated (redacted by FDA) Chopper (redacted by FDA), which they had previously identified as a harborage source for the strain of Listeria monocytogenes isolated in their facility since at least 2017, on March 4, 2024, was the source of the recontamination. In their Feb. 13, 2024, written response, they state, after removing (redacted by FDA) Chopper (redacted by FDA) on Nov. 17, 2023, that the motor shaft seal had been compromised and the motor was discarded, and they indicated they did not intend to re-introduce the equipment into the processing area. However, after the motor was discarded, (redacted by FDA) Chopper (redacted by FDA) was repaired, cleaned, and sanitized; firm management made the decision to reinstall the equipment. They reported (redacted by FDA) Chopper (redacted by FDA) was only used to process chicken in their Buffalo Chicken dip manufactured from March 6-14, 2024. In addition, they stopped (redacted by FDA) production to allow for more time cleaning and sanitizing. The firm also made additional improvements to their SSOPs, including cleaning, and sanitizing of floor drain locks and brackets and braces on mixing bowls. In addition, on April 5, 2024, they confirmed they were no longer manufacturing USDA FSIS regulated food in their Easley, SC facility.

In the firm’s written response dated April 9, 2024, they report that after being notified by USDA FSIS on March 18, 2024, of the environmental and finished product positive samples collected by USDA FSIS on March 12, 2024, they permanently removed (redacted by FDA) Chopper (redacted by FDA) from their processing area and completed intensified cleaning and sanitizing. In addition, they broke down equipment used to manufacture USDA FSIS-regulated product on March 12, 2024 (including (redacted by FDA) and (redacted by FDA) processing lines), performed intensified cleaning, and disposed of some common utensils. The firm stated no FDA-regulated product was manufactured on the equipment used to manufacture USDA FSIS-regulated product on March 12, 2024, until they completed the full equipment breakdown and sanitation and felt confident no FDA product was impacted by the findings. On March 18, 2024, they collected (redacted by FDA) environmental swab samples for Listeria spp. and all samples were negative. All product sampling from that day was negative as well.

However, given the repeated detection of the same strain of Listeria monocytogenes over several years and the inspectional findings, FDA continues to be concerned about their ability to maintain a sanitary environment, implement an effective sanitation program, and take adequate corrective actions. FDA recommends that they continue to identify potential harborage sites in their processing environment and implement the necessary procedures and controls to ensure Listeria monocytogenes does not contaminate their environment or their RTE food products. 

Current Good Manufacturing Practice Requirements:

The firm did not clean and sanitize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food packaging materials, as required. Specifically, on Dec. 14, 2023, FDA investigators observed cleaning and sanitation of their Production Room (redacted by FDA) ((redacted by FDA) line). During the cleaning and sanitizing of Production Room (redacted by FDA), an employee used a scrubbing tool to unclog a floor drain located approximately 12-inches from the finished product fill line of (redacted by FDA). The water from the clog was observed splashing onto the cup conveyor and paneling, which are food-contact surfaces on the (redacted by FDA) Line. Furthermore, the scrubbing tool is stored in the floor tool storage area in Production Room (redacted by FDA), wher FDA detected Listeria innocua in an environmental swab taken from a sanitation squeegee head.

The full warning letter can be viewed here.