WARNING LETTER
Gracie's Kitchens, Inc.
MARCS-CMS 701613 —
September 03, 2025
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Ralph J. Parillo
Recipient Title
President
Gracie's Kitchens, Inc.
211 Food Terminal Plaza
New Haven
,
CT
06511-5911
United States
Issuing Office:
Human Foods Program
United States
September 3, 2025
WARNING LETTER
CMS # 701613
Dear Mr. Parillo:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 211 Food Terminal Plaza, New Haven, CT, from November 4-25, 2024. Your facility manufactures ready-to-eat (RTE) fresh cut fruits and vegetables, sauces, and non-RTE (NRTE) vegetable products. 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 swabs 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 swabs, we have determined that the RTE food products manufactured in your facility 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 further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing deviations found at your facility. We received your responses to FDA’s environmental sample findings via email on November 23, 27, and 30, 2024. We also received your responses to the FDA-483 via email on December 3, 20, and 21, 2024, describing corrective actions taken and planned by your facility. Based on our review of the inspectional findings and the responses that your facility provided, we are issuing this letter to advise you of FDA’s continuing concerns and to 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):
1. You did not 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).
Specifically, your facility processes refrigerated RTE fresh cut fruits and vegetables that are exposed to the environment prior to packaging, where they may be contaminated with environmental pathogens such as
L. monocytogenes
. These RTE fresh cut fruit and vegetable products do not receive any lethal treatment or otherwise include a control measure that would significantly minimize the pathogen. Your hazard analysis identifies biological hazards at the
(b)(4)
process steps as reasonably likely to occur and identifies the Sanitation Standard Operating Procedures (SSOP) Program to control the hazards. As evidenced by recurring environmental findings of
L. monocytogenes
in your facility, 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 the environmental pathogen
L. monocytogenes
, as required by 21 CFR 117.135(a)(1) and (c)(3), and as further discussed below.
Listeria monocytogenes in your facility
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 is able to 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, a foodborne illness, 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.
Our inspection included the collection of environmental swabs from various areas in your processing facility during production on November 4, 2024. FDA laboratory analysis of environmental sample #1239780 collected at your facility on November 4, 2024, confirmed that
(b)(4)
of the
(b)(4)
environmental swabs were positive for
L. monocytogenes
. The positive swabs were recovered, while your facility was processing RTE vegetables and fruit, from food contact surfaces in the main production area, including:
A cutting board on the surface of Table
(b)(4)
holding a tray of raw chicken on one side and packed potatoes on the other side.
The interior of a grey bin next to Table
(b)(4)
holding artichokes in the process of being stuffed.
We note that this was not the first time that
L. monocytogenes
was found in environmental swabs collected at your facility. On April 9, 2024, FDA detected
L. monocytogenes
in
(b)(4)
environmental swab from the left side of the floor surface area in the cooler.
Whole genome sequencing (WGS) analysis was conducted on the
(b)(4)
L. monocytogenes
isolates obtained from the FDA environmental swabs described above and collected on November 4, 2024, and April 9, 2024, respectively. The WGS analysis determined that the
(b)(4)
isolates represent
(b)(4)
different strains of
L. monocytogenes
. The isolate obtained from the positive environmental swab recovered from the cutting board on the surface of table
(b)(4)
matches clinical isolates demonstrating that this strain is known to cause human illness. We advised you of these WGS results on November 22, 2024, during a conference call. On November 28, 2024, your facility recalled all RTE fruit and vegetable products manufactured at your facility from November 4-13, 2024, because they had the potential to be contaminated with
L. monocytogenes
.
The reoccurring presence of
L. monocytogenes
in your facility demonstrates that your sanitation procedures have been inadequate to significantly minimize or prevent
L. monocytogenes
in your facility. Appropriate control of
L.
monocytogenes
in a food processing environment requires knowledge of the unique characteristics of the organism and implementation of the hygienic practices necessary to control this pathogen. Once
L. monocytogenes
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 can survive and grow, and to apply controls or take corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
In addition, in reviewing your facility’s environmental monitoring program, we note that you have repeatedly found
L. monocytogenes
and Listeria spp. through your own testing. A review of the laboratory reports dated May 7, May 9, May 11, May 18, May 20, and May 22, 2024, found Listeria spp. was recovered from multiple non-food-contact surfaces, including but not limited to the concrete floor patch by table
(b)(4)
sampled on May 8, May 14, and May 16, 2024. On May 16, 2024, the concrete patch by table
(b)(4)
was also positive for
L. monocytogenes
.
Your response to the above
L. monocytogenes
findings included recalling all RTE fruit and vegetable products manufactured at your facility from November 4-13, 2024, because they had the potential to be contaminated with
L.
monocytogenes
. Your November 23, 2024, response to the inspectional findings reported vector swabbing, extensive and thorough cleaning of the entire facility with particular focus on the Table
(b)(4)
area and its surrounding vicinity, in addition to working with a third-party consultant. Given the repeat history of positive
L. monocytogenes
findings in your processing environment and most recent inspectional findings, we continue to be concerned about your ability to maintain a sanitary environment. A consultant with expertise in the control of
L. monocytogenes
may provide guidance in establishing such controls and procedures. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
2. You did not implement your written procedures for monitoring a preventive control, including the frequency with which they are to be performed, as required by 21 CFR 117.145(a).
Specifically, you are not following your environmental monitoring procedure titled “
(b)(4)
.” Your environmental monitoring program identifies
(b)(4)
sampling frequency but not the number of sites to be tested. You provided your environmental sampling test results from April 2024 to November 2024 to the FDA investigator. Review of these records found you were not complying with this frequency as you did not perform sampling at all in July, August, and October, and you only collected swabs once in June and September. Also, your environmental monitoring procedure requires,
(b)(4)
.” You are not following your outlined procedure. Your third-party laboratory analyzes your environmental swabs for
Listeria spp
. and for
L. monocytogenes
. A review of the laboratory reports dated May 7, May 11, May 18, and May 20, 2024, found
Listeria spp
. was recovered from multiple non-food-contact surfaces, including but not limited to the concrete floor patch by table
(b)(4)
sampled on May 8, May 14, and May 16, 2024. On May 16, 2024, the concrete patch by table
(b)(4)
was also positive for
L. monocytogenes
. You stated that
(b)(4)
. You did not perform any vector testing, intensified cleaning, and sanitizing, nor did you conduct additional activities to identify sources and routes of contamination. Furthermore, our review of the laboratory reports found environmental swabs collected from the wheels on green cart
(b)(4)
on May 2, 2024, and green cart
(b)(4)
on May 8, 2024, were positive for
Listeria spp
. These carts move freely from your main processing area to other areas of the facility, including the cooler and loading dock. You stated that
(b)(4)
, but you did not document this activity or any other follow-up activities. Retesting and vector testing were not conducted, and no other documentation was provided to show whether corrective actions were implemented.
We acknowledge that your facility performs weekly EMP testing per your corrective actions following the positive test results relayed in November 2024, however, no information was provided on the results of such testing.
Your December 20-21, 2024, response letter included a revised environmental monitoring procedure, “
(b)(4)
.” (EMP) dated November 25, 2024. According to this program, “
(b)(4)
.” Your environmental monitoring program did not identify the location of surfaces to be sampled, or if you intend to sample food contact or non-food contact surfaces. We will verify the effectiveness of your corrective actions during our next inspection.
3. You did not appropriately evaluate all known or reasonably foreseeable hazards to determine whether there are hazards requiring a preventive control for your RTE packaged food products, as required by 21 CFR 117.130(a)(1).
Specifically, your hazard analysis at the “
(b)(4)
” step failed to identify undeclared allergens due to incorrect labeling as a food safety hazard requiring a preventive control. Your facility handles and manufactures stuffed vegetable products, including stuffed artichokes and stuffed mushrooms containing the following allergens: fish (pollack, whiting), wheat, sesame, crustacean shellfish (crab), egg, soy, and milk. Undeclared allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for labeling the finished food to ensure that all food allergens are included on the label (see 21 CFR 117.135(c)(2)(ii)). Your allergen control program and label creation procedures do not ensure that the allergens are correctly declared on the finished product label and that the finished product is packaged in the right box since there are no specific procedures to check the ingredients on finished product labels with those of all the ingredients comprising the finished product. The procedures do not include management components of monitoring, corrective action, and verification procedures. Your vice president told the FDA investigator that
(b)(4)
, but this activity is not monitored or documented.
We note that a previous recall was initiated by your facility for "
(b)(4)
" with "
(b)(4)
" as the finished product label did not declare wheat and sesame allergens, despite wheat and sesame being included as product ingredients. Your facility did not document corrective actions following this recall, nor has the allergen program been updated to ensure the hazard of undeclared allergens due to incorrect label is controlled. You stated your
(b)(4)
. Your procedures were not updated with control measures and management components. This is a repeat observation from the previous inspection(s) conducted on May 8, 2024.
Your response dated December 20-21, 2024, provided a HACCP plan with a Hazard Analysis Worksheet which appears to address the above hazards under the CCP
(b)(4)
Packaging and Labeling. The HACCP plan refers to the records “
(b)(4)
,” and refers to a label approval process for control of labels. This procedure was not included with your response. The procedure obtained during the inspection entitled “
(b)(4)
” dated June 4, 2024, does not specify how ingredient statements on finished product labels are checked against raw materials used in the product. Your response also references a production worksheet used in the label process, a receiving log for allergens/ingredients and master lists with ingredient lists, but no example documents were provided or procedures directing how such verification is conducted.
4. Your written allergen preventive control did not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use, as required by 21 CFR 117.135(c)(2) and (c)(3). Specifically:
Your facility handles and processes stuffed and breaded vegetables that contain different allergen profiles such as stuffed mushrooms and stuffed artichokes that contain allergens including wheat, soy, milk products, fish, crustacean shellfish (crab), sesame, and eggs. These products containing different allergen profiles are processed on the same day, in the same rooms, and on shared equipment with fresh cut fruit and vegetables.
Your hazard analysis for RTE fresh cut vegetables and fruits identified the hazard of “allergen cross contamination” as reasonably likely to occur at the “
(b)(4)
,” “
(b)(4)
,” steps and as not likely to occur at the “
(b)(4)
” step. Your hazard analysis identified the practice of producing and packaging products containing allergens at the end of vegetable production to eliminate any chance of contamination as a measure to prevent the hazard. Your hazard analysis also identified the SSOP Program, “
(b)(4)
” Rev: 03/03/23, to control the hazard. Specifically, your “
(b)(4)
” Rev: 03/03/23 states the facility’s allergen control measures for “
(b)(4)
” include “
(b)(4)
.” However, your allergen preventive control program does not specify how sequencing will be accomplished or what safeguards will be in place to assure allergen ingredients are stored separately. The program does not contain written monitoring procedures including frequency, corrective actions, and verification procedures. Furthermore, you do not have records documenting activities performed. On November 4, 2024, your facility was processing stuffed artichokes on table
(b)(4)
, which contained wheat, soy, sesame, and milk allergens while concurrently packaging baby potatoes on the same equipment.
Your response dated December 20-21, 2024, addresses the retraining of supervisors on proper sequencing of allergen containing ingredients. The response states, “
(b)(4)
” and “
(b)(4)
.” Your response did not include a revised allergen program providing any new details as to the actual controls to be implemented to assure allergen control. Your “
(b)(4)
,” in place during the inspection dated March 3, 2023, was found inadequate as detailed above.
Supply-Chain Program (21 CFR Part 117, Subpart G)
5. Your written supply-chain program did not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented, as required by 21 CFR 117.410(c). Specifically, your written procedure does not ensure control of vegetative bacterial pathogens in raw materials or other ingredients via your supply-chain program and your RTE products do not undergo further processing to control vegetative bacterial pathogens.
Your facility processes refrigerated RTE fresh cut vegetables and fruit including refrigerated RTE cut cantaloupe. Your facility’s hazard analysis identifies biological hazards at the
(b)(4)
step as reasonably likely hazards to occur and identifies a supplier approval program, “
(b)(4)
,” Rev 03/03/19 to control that hazard. Under the “
(b)(4)
section of your “
(b)(4)
” it states, “
(b)(4)
.” Your written procedure does not specifically require review of annual onsite audit results to ensure control of vegetative bacterial pathogens (e.g.,
Salmonella
and
L. monocytogenes
) in raw materials or other ingredients via your supply-chain program.
Additionally, your facility does not provide a
(b)(4)
step to control vegetative bacterial pathogens in your RTE fresh cut vegetables and fruit products.
L. monocytogenes
and
Salmonella
are hazards that can cause serious adverse health consequences or death to humans or animals. Therefore, an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw materials or other ingredients from the supplier and at least annually thereafter (see 21 CFR 117.430(b)(1)(ii))
Furthermore, you did not follow your written supply-chain procedure, “
(b)(4)
” Rev 03/03/19 at the time of the inspection. For example, the written procedure states that “
(b)(4)
.” On November 4, 2024, FDA investigators observed your facility processing cantaloupe and the sticker on the cantaloupe read “
(b)(4)
”. Your facility explained that you approved the distributor of this cantaloupe, but you did not approve the grower, Fisher Ranch, as required by your procedure and 21 CFR 117.420(a). Under 21 CFR 117.420(a), the receiving facility must approve suppliers in accordance with the requirements of 21 CFR 117.410(d), and document that approval, before receiving raw materials and other ingredients received from those suppliers. This is a repeat observation from the previous inspection conducted on May 8, 2024.
Your response dated December 20-21, 2024, reports that
(b)(4)
. There is no mention of an adequate supplier approval program as a “
(b)(4)
.”
Current Good Manufacturing Practice (21 CFR part 117, Subpart B):
FDA has found non-pathogenic
Listeria spp
. including
Listeria innocua
,
Listeria welshimeri
, and
Listeria seegligeri
in your facility in March 2022, March 2023, April 2024, and November 2024. The presence of non-pathogenic
Listeria
species is indicative of insanitation and conditions that are suitable for the survival and/or growth of pathogenic
L. monocytogenes
. The presence of non-pathogenic Listeria spp. further demonstrates that the cleaning and sanitation procedures used in your facility are inadequate to control pathogenic
L. monocytogenes
.
During our recent inspection of your facilty, our investigators observed serious deviations from the CGMPS, including:
6. You did not clean and sanitize your utensils and equipment in a manner that protects against contamination of food-contact surfaces, as required by 21 CFR 117.35(a). On November 4, 2024, FDA investigators observed employees using high pressure hoses during cleaning and sanitizing after processing raw chicken products and prior to processing RTE fresh vegetables and fruits, in the following manner:
Rinsing tables
(b)(4)
where water routinely splashed off the walls on to the cutting tables (food contact surface). FDA isolated
L. monocytogenes
from a swab collected from the cutting board on table
(b)(4)
, which was used in the processing of RTE peppers and onions and NRTE potatoes.
Spraying the floors after cleaning,where water was splashing off the floor on to the legs and frame of the cutting board tables and misting on to the surface of the cutting boards. FDA’s November 4, 2024, environmental swab isolated
L. innocua
from the floor in front of table
(b)(4)
, which was then used to process RTE squash noodles and NRTE butternut squash.
Spraying the floor mats, where water was splashing off the mats, floor, and drain onto equipment, including but not limited to the Urschel chopper and finished product packaging that are used to package both RTE and NRTE finished products. The Urschel chopper was later used to process NRTE butternut squash.
High pressure water hoses were routinely placed on the floor and employees conducting sanitation were observed handling these hoses that were touching the floor with their gloved hands. After handling the hoses, the employees touched food surfaces including cutting boards and the middle conveyor belt with their gloved hands. The employees did not change their gloves or wash their hands. Furthermore, L. innocua was isolated from the FDA environmental swab collected on November 4, 2024, from the floor mat in front of table
(b)(4)
, and the high-pressure water hose was routinely placed on the floor underneath table
(b)(4)
during cleaning and sanitation.
During cleaning of white totes, water was observed splashing off the floor on to the bin stands and metal racks. The bin stands are used to hold totes of RTE produce and the metal racks were used to hold trays of RTE products.
Your December 20-21, 2024, response letter relayed your new policy regarding high-pressure hoses as: “
(b)(4)
.” This practice still presents a contamination potential.
The use of high-pressure hoses creates overspray and aerosols that can transfer and spread pathogens from the environment to food contact surfaces, and floors are common sources of environmental pathogens such as L. monocytogenes.
A review of the “
(b)(4)
” dated November 24, 2024, submitted with your email response dated November 30, 2024, found no reference to high-pressure hose use. Further, this SOP lacks some directives regarding cleaning/sanitizer materials use/dilutions.
7. Your plant was 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 by 21 CFR 117.20(b)(4). Specifically:
On November 4, 2024, condensate droplets were dripping from the fan guard of the refrigeration unit directly to the floor next to the packaging machine conveyor belt. This is a high foot traffic area.
On November 4, 2024, condensate droplets were forming on the fan guard of the refrigeration unit in the walk-in cooler adjacent to metal racks containing covered and uncovered RTE and NRTE products.
8. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). On November 4, 2024, the FDA investigator observed the plant floor in the middle room, at the doorways, and inside the walk-in cooler area is rough with exposed concrete, and pooling water was observed. There was an apparent red visible liquid (appeared to be liquid from raw meat products) observed pooling on the floor at the doorway between the middle and main processing. This is a high foot traffic area with employees, pallet jacks, and rolling carts moving freely between the front to the rear
(b)(4)
dumpster area and walk-in cooler during processing of RTE vegetables and fruits.
This is a repeat observation from the previous inspections conducted on May 8, 2024, April 7, 2022, and October 1, 2021.
Your December 20-21, 2024, response to violations 6 and 7 above also report refrigeration units were disassembled and cleaned on November 23, 2024. Supervisors were reportedly instructed to pay attention to units and notify management/ production manager if condensation is forming or dripping. It was relayed that Daily pre / operational checks are done at minimum 2x a day and employee retrained on proper monitoring of the units. However, your response does not address the conditions reported above concerning the rough exposed concrete and pooling water/food residues through which foot traffic and cart traffic traverse. These conditions were reported in the prior inspections of April 9, 2024, to May 8, 2024, and March 22, 2022, to April 7, 2022. Further, FDA laboratory analysis of environmental sample #1216651 collected at your facility on April 9, 2024 during the FDA inspection conducted on April 9, 2024 – May 8, 2024 confirmed swabs from several of the wheels of rolling carts and the pallet jack tested positive for
Listeria innocua
(swabs
(b)(4)
);
(b)(4)
swabs on the floor and floor drain outside the walk-in cooler tested positive for
Listeria innocua
(swabs
(b)(4)
);
(b)(4)
swab on the handle surface area of squeegee
(b)(4)
tested positive for
Listeria innocua
(swab
(b)(4)
);
(b)(4)
swab on the blue pallet underneath the packing machine surface area tested positive for
Listeria innocua
(swab
(b)(4)
); and
(b)(4)
swab tested positive for
L. monocytogenes
on the floor inside the walk-in cooler in front of the rear door leading to the rear loading dock (swab
(b)(4)
).
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist 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 facility 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 adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within fifteen (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 fifteen (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 reply should be directed to Lillian C. Aveta via email at HFP-OCE-Produce@fda.hhs.gov. If you have any questions, you may email at HFP-OCE-Produce@fda.hhs.gov.
Sincerely,
/S/
Maria S. Knirk, J.D., M.B.A.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
09/30/2025
Regulated Product(s)
Food & Beverages