WARNING LETTER
Discover Fresh Foods, LLC
MARCS-CMS 677021 —
June 26, 2024
Delivery Method:
UPS Overnight
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Andrew Smart
Recipient Title
CEO
Discover Fresh Foods, LLC
600 S. Main Street 3rd Floor
Greenville
,
SC
29601
United States
Issuing Office:
Division of Human and Animal Food Operations East III
United States
June 26, 2024
RE: CMS # 677021
WARNING LETTER
Dear Mr. Smart:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 211 Pine Road, Easley, SC, from December 11, 2023, through January 22, 2024. Your firm manufactures refrigerated ready-to-eat (RTE) dips and spreads. During our inspection of your facility, our investigators found serious violations of 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). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental sample found the presence of
Listeria monocytogenes (L. monocytogenes)
, a human pathogen, in your facility.
Based on FDA’s inspectional findings and the analytical results for the environmental samples, we have determined that your RTE dips and spreads are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (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. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of 21 CFR Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.
FDA’s inspection resulted in issuance of an FDA-483, Inspectional Observations, listing deviations found during our inspection. We received your responses to FDA’s environmental sample findings on December 28, 2023, and January 4, 10, and 17, 2024. We have also received your responses to the FDA-483 on February 12, 2024, and April 9, 2024, as well as your weekly updates most recently provided May 24, 2024, describing corrective actions taken by your firm. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We discuss your responses below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
You are 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 your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, 21 U.S.C. § 342 or § 343(w), to comply with 21 CFR 117.135(a)(1).
Your facility manufactures RTE food products that are exposed to the environment prior packaging and after any pathogen lethal treatment, where they may be contaminated with environmental pathogens such as
L. monocytogenes
. Your packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation
1
lethal to the pathogen) that would significantly minimize the pathogen. Your 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, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of recontamination with environmental pathogens, as required by 21 CFR 117.135(a)(1) and (c)(3), and as further discussed below.
L. 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 where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism can grow and survive, and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with
L. 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 your RTE dips and spreads. However, FDA laboratory analysis of environmental sample #1242488 collected on December 13, 2023, found that three (3) out of the 99 total environmental swabs were positive for
L. monocytogenes
. The positive swabs were recovered from non-food-contact surfaces in Production Room
(b)(4)
, and
(b)(4)
) during the production of Taste of the South Fried Pickle Dip, and the underside of the top level of the red cart in
(b)(4)
. FDA laboratory analysis of sample #1242488 also found three (3) out of the 99 swabs were positive for
Listeria innocua (L. innocua)
. These swabs were obtained from your
(b)(4)
transfer pump bottom frame, trash bin wheel, and bottom of sanitation squeegee.
During and prior to our inspection, you 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
L. monocytogenes
in finished product and environmental samples collected in your facility in 2018 and 2023. USDA FSIS detected
L. monocytogenes
in Buffalo Style Chicken Dip in 2018 and 2023, and both products were destroyed. USDA FSIS also detected
L. monocytogenes
in six (6) 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
L. monocytogenes
in a retail sample of your Chipotle Chicken Salad in 2017.
On December 28, 2023, we notified you that we detected
L. monocytogenes
in three (3) swabs from FDA Sample 1242488. After receiving the results, your 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. You began an intensified cleaning process on December 29, 2023, for the three (3) areas that tested positive for
L. monocytogenes
. You collected
(b)(4)
of environmental swabs on these surfaces during
(b)(4)
, and
(b)(4)
. You did not detect
L. monocytogenes
in your additional environmental samples.
Whole Genome Sequencing (WGS) analysis was conducted on the following
L. monocytogenes
isolates obtained from FDA, USDA FSIS, and FDACS retail product sample, environmental and finished products samples, as follows:
• three (3)
L. monocytogenes
isolates obtained from FDA environmental sample 124288 in 2023;
• four (4)
L. monocytogenes
isolates obtained from USDA FSIS environmental samples in 2023;
• one (1)
L. monocytogenes
isolate obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2023;
• two (2)
L. monocytogenes
isolates obtained from USDA FSIS environmental samples in 2018;
• one (1)
L. monocytogenes
isolates obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2018; and
• one (1)
L. monocytogenes
isolate obtained from Chipotle Chicken Salad collected by FDACS in 2017.
Based on the results of the WGS analysis, the twelve (12) isolates represent a single strain of
L. monocytogenes
. The presence of the same strain of
L. monocytogenes
over multiple years indicates that there has been a resident pathogen in your facility since at least November 2017. We advised you of these WGS results via conference calls on January 10 and 17, 2024.
In addition, in November 2023, you also isolated
L. monocytogenes
in thirteen (13) zone
(b)(4)
and zone
(b)(4)
environmental swabs and three (3) finished product samples of burnt ends dip. You performed intensified cleaning and sanitizing of food-contact equipment and revised your (SSOPs). Subsequently, you destroyed finished products associated with food-contact surfaces positive for
L. monocytogenes
and finished product found to contain
L. monocytogenes
. You decommissioned and removed your
(b)(4)
Chopper
(b)(4)
from your facility on November 17, 2023, which you suspected was the source of the pathogen.
Your response dated February 12, 2024, included a summary of your responses to the above-mentioned pathogen findings not limited to, retaining food safety counsel, removing equipment suspected as the source of harborage, expanding your sanitation staff, updating your 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 your employee Good Manufacturing Practices (GMPs), eliminating plastic pallets, and filling in unnecessary drains. In addition, you collected
(b)(4)
environmental samples since November 2023, which have all been followed by an intensified cleaning including QA observations (e.g., verification of cleaning), increased sanitizer concentration followed by
(b)(4)
days of follow-up swabs during
(b)(4)
, and
(b)(4)
production. You stated you have not found
Listeria
spp. during any retests of equipment. However, you detected
Listeria
spp. in two (2) additional non-food-contact surfaces on December 29, 2023, and on January 3, 2024, on the floor in Production Room
(b)(4)
and on the floor in the
(b)(4)
room, respectively.
On February 2, 2024, USDA FSIS notified FDA
L. monocytogenes
was detected in two (2) additional environmental swabs collected from non-food-contact surfaces (e.g., cart wheels) at your facility. WGS analysis of the isolates indicates that one (1) of the isolates represents the same strain of
L. monocytogenes
present since at least November 2017 mentioned above and one (1) of the isolates represents a strain not previously identified in your facility.
Per your response dated February 12, 2024, you made changes to your SSOPs for cleaning on a routine basis and after an environmental positive of equipment or the facility. You eliminated additional routes of pathogen recontamination in the processing area by restricting movement of equipment and utensils and employee traffic flow. You made sanitary design changes such as installing foot foamers at all entrances to the food processing area. In your updated response dated February 23, 2024, you implemented a test and hold procedure for both FDA and USDA FSIS finished products and made additional changes to your SSOPs. Since that date, you reported you had not detected L. monocytogenes in any FDA finished product samples. As of March 11, 2024, you reported all finished product sample results were negative. However, you did detect
Listeria
spp. on the chassis of a mixing bowl in Production Room
(b)(4)
(
(b)(4)
) and conducted intensified cleaning and swabbing. In addition, you completed floor replacement and/or repair throughout the processing area.
Despite your corrective actions, on March 18, 2024, USDA FSIS notified you they detected
L. 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
L. monocytogenes
previously found in your facility since at least November 2017. These findings demonstrated that your corrective actions had been inadequate to significantly minimize or prevent
L. monocytogenes
in your facility. We advised you of these WGS results via a conference call on April 5, 2024.
During our call on April 5, 2024, you stated you believe the re-installation of the remediated
(b)(4)
Chopper
(b)(4)
, which you had previously identified as a harborage source for the strain of
L. monocytogenes
isolated in your facility since at least 2017, on March 4, 2024, was the source of the recontamination. In your February 13, 2024, written response, you state, after removing
(b)(4)
Chopper
(b)(4)
on November 17, 2023, that the motor shaft seal had been compromised and the motor was discarded, and you indicated you did not intend to re-introduce the equipment into the processing area. However, after the motor was discarded,
(b)(4)
Chopper
(b)(4)
was repaired, cleaned, and sanitized; firm management made the decision to reinstall the equipment. You reported
(b)(4)
Chopper
(b)(4)
was only used to process chicken in your Buffalo Chicken dip manufactured from March 6 through March 14, 2024. In addition, you stopped
(b)(4)
production to allow for more time cleaning and sanitizing. You also made additional improvements to your SSOPs, including cleaning, and sanitizing of floor drain locks and brackets and braces on mixing bowls. In addition, on April 5, 2024, you confirmed you were no longer manufacturing USDA FSIS regulated food in your Easley, SC facility.
In your written response dated April 9, 2024, you 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, you permanently removed
(b)(4)
Chopper
(b)(4)
from your processing area and completed intensified cleaning and sanitizing. In addition, you broke down equipment used to manufacture USDA FSIS-regulated product on March 12, 2024 (including
(b)(4)
and
(b)(4)
processing lines), performed intensified cleaning, and disposed of some common utensils. You stated no FDA-regulated product was manufactured on the equipment used to manufacture USDA FSIS-regulated product on March 12, 2024, until you completed the full equipment breakdown and sanitation and felt confident no FDA product was impacted by the findings. On March 18, 2024, you collected
(b)(4)
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
L. monocytogenes
over several years and the inspectional findings, we continue to be concerned about your ability to maintain a sanitary environment, implement an effective sanitation program, and take adequate corrective actions. We recommend that you continue to identify potential harborage sites in your processing environment and implement the necessary procedures and controls to ensure
L. monocytogenes
does not contaminate your environment or your RTE food products. It is critical that you ensure your environmental monitoring program is able to detect
L. monocytogenes
and that you take timely robust corrective actions in response to environmental positives.
With respect to your finished product testing, although you have not identified a finished product positive since February 2024, you should not rely on that testing to ensure your products are not adulterated as microorganisms are not uniformly distributed in product. You should continue to monitor your sanitation preventive control and verify it is working through a robust environmental monitoring program with associated aggressive corrective actions when
Listeria
is found in your facility environment. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during a future inspection.
Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B):
You 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 by 21 CFR 117.35(a). Specifically, on December 14, 2023, our investigators observed cleaning and sanitation of your Production Room
(b)(4)
(
(b)(4)
line). During the cleaning and sanitizing of Production Room
(b)(4)
, an employee used a scrubbing tool to unclog a floor drain located approximately 12-inches from the finished product fill line of
(b)(4)
. The water from the clog was observed splashing onto the cup conveyor and paneling, which are food-contact surfaces on the
(b)(4)
Line. Furthermore, the scrubbing tool is stored in the floor tool storage area in Production Room
(b)(4)
, where FDA detected
L. innocua
in an environmental swab taken from a sanitation squeegee head.
In your response dated February 12, 2024, you state that you added the use of a
(b)(4)
and use of
(b)(4)
during the cleaning of drains. You revised that your SSOP require that employees perform this sanitation at the end of shift and leave the area immediately upon completion. You also revised your SSOP to state if cleaning of drains results in possible contamination of food-contact equipment, that food-contact equipment must undergo full cleaning and sanitation. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during a future inspection.
This letter is not intended to be an all-inclusive list of violations at your facility or 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. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so 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 sent to LT N’Jere English, Ph.D., Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, NE, Atlanta, GA 30309. If you have any questions regarding the content of this letter, please contact N’Jere English at 404-253-2242 or email Njere.English@fda.hhs.gov.
Sincerely,
/S/
Ingrid A. Zambrana
Program Division Director
Office of Human and Animal Foods Operations – Division East III
Cc: William G. Bruce, Director of Operations
211 Pine Rd.
Easley, SC 29642
_____________________
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You incorporate preservatives into your finished product formulation, including sodium benzoate and Nicin®, but you have not identified these chemicals as preventive control measures for pathogens.
Content current as of:
07/16/2024
Regulated Product(s)
Food & Beverages