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WARNING LETTER

DO&CO Aktiengesellschaft/DO&CO, Inc. MARCS-CMS 717773 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Attila Dogudan, Owner
Recipient Title
Selatin Mujezic, Head of Operations
DO&CO Aktiengesellschaft/DO&CO, Inc.

Stephansplatz 12
1010 Vienna
Austria

headoffice@doco.com
sal.mujezic@doco.com
Issuing Office:
Human Foods Program

United States

March 30, 2026

WARNING LETTER

CMS #717773

Dear Messrs. Dogudan and Mujezic:

The United States Food and Drug Administration (FDA) inspected four (4) of your airline catering DO&CO, Inc. facilities during a period from June 2025 to August 2025 (exact dates listed below). FDA initiated these inspections after our 2024 for-cause inspections at (b)(4) of your locations resulted in an in-person DO&CO, Inc. corporate Regulatory Meeting in January 2025 due to significant sanitation issues and widespread concerns with Listeria findings in RTE finished products and on direct food-contact surfaces in several facilities.

We are issuing this letter to you as the Owner of the corporation responsible for the facilities (i.e., referenced in this letter as your “facility” or “facilities”), because we found serious deviations during our inspections of these (b)(4) facilities. FDA 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) during the inspections. Additionally, during the inspections FDA collected environmental samples (i.e., swabs) from various areas in each of the processing facilities, including areas in proximity to food and food-contact surfaces.

FDA laboratory analyses of the environmental swabs collected during the 2024 inspections found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in (b)(4) of your (b)(4) inspected facilities. Additionally, it was found that your finished product test results for your New York and Detroit facilities were positive for L. monocytogenes (New York) and L. monocytogenes, Staphylococcus aureus, and Bacillus cereus (Detroit). During the 2025 inspections, environmental samples collected by FDA and your firm found the presence of L. monocytogenes within (b)(4) of your (b)(4) inspected facilities, and it was determined that finished product testing had been ceased by your firm. Whole Genome Sequencing (WGS) analysis of the environmental findings demonstrated the presence of multiple resident strains of L. monocytogenes within a single facility that were also shared between these facilities.

Based on FDA’s inspectional findings and analytical results revealing L. monocytogenes in your production environments, we have determined that your ready-to-eat (RTE) food products manufactured in your Detroit “(b)(4)” facility and your main New York 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 whereby they may have been 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 www.fda.gov.

At the conclusion of the four (4) follow-up inspections, FDA issued FDA Form 483s, Inspectional Observations (FDA-483s), listing deviations found at each inspected facility. We are issuing this letter to advise you of FDA’s continuing concerns regarding the (b)(4) inspected facilities and to provide detailed information describing the findings at your facilities. We discuss your responses below.

Facilities Inspected
FDA inspected the following (b)(4) airline catering facilities located in Michigan (3) and New York:

1. DO&CO New York Catering, Inc. – located at 14932 132nd Street, Jamaica, NY 11430, inspected from June 9, 2025 to July 22, 2025, which manufactures RTE airline foods in bulk to be transferred to your plating facility (also located in New York). We acknowledge receipt of your initial response dated August 11, 2025, which included a description of the corrective actions taken and planned. We also acknowledge your further “CAPA Status Updates” provided September 12, 2025; October 9, 2025; November 7, 2025, December 8, 2025; January 11, 2026, February 9, 2026; and March 11, 2026.

2. DO&CO Detroit, Inc. “(b)(4)” facility – located at (b)(4) West Service Drive, Detroit, MI 48242, inspected from July 17, 2025, to August 18, 2025, which is the dishwashing facility for your Detroit “(b)(4)” facility (and “(b)(4)” facility when needed). We acknowledge receipt of your initial response dated September 9, 2025, which included a description of the corrective actions taken. 

3. DO&CO Detroit, Inc. “(b)(4)” facility – located at 1 Village Center Drive, Van Buren Township, MI 48111, inspected from July 14, 2025, to August 18, 2025, which manufactures RTE airline foods in bulk to be transferred to your Detroit “(b)(4)” facility for plating. We acknowledge receipt of your initial response dated September 9, 2025, which included a description of the corrective actions taken and planned. We also acknowledge your further “CAPA (b)(4)” for all your Detroit facilities provided September 26, 2025; October 10, 2025; November 7, 2025; December 8, 2025; January 11, 2026; February 10, 2026; and March 9, 2026.

4. DO&CO Detroit, Inc. “(b)(4)” facility – located at 33370 Trade Center Drive, Romulus, MI 48174, inspected from July 23, 2025 to August 18, 2025, which receives bulk RTE food from “(b)(4)” for plating and distribution. We acknowledge receipt of your initial response dated September 9, 2025, which included a description of the corrective actions taken and planned. We also acknowledge your further “CAPA (b)(4)” for all your Detroit facilities provided September 26, 2025; October 10, 2025; November 7, 2025; December 8, 2025; January 11, 2026; February 10, 2026; and March 9, 2026.

Hazard Analysis & Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. Your written sanitation preventive controls did not include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling, to comply with 21 CFR 117.135(c)(3).

(b)(4) of your inspected facilities process RTE airline meals that are exposed to the environment prior to packaging, where they may be contaminated with environmental pathogens such as L. monocytogenes. Your hazard analyses for RTE airline meals manufactured at your Detroit “(b)(4)” facility, Detroit “(b)(4)” facility, and New York facility all identified the hazard of recontamination with Listeria as requiring a preventive control at your (b)(4) processing steps, stating that “(b)(4)”.

Personnel and equipment movement can serve as mechanisms for cross-contamination. Although your firm included evaluating traffic patterns as a potential source of contamination as a corrective action following the 2024 inspection of your Detroit “(b)(4)” facility, your written sanitation preventive control procedures do not address traffic control, including carts traveling between DO&CO, Inc. facilities, within your new Detroit “(b)(4)” or “(b)(4)” facilities. The 2025 inspection of your Detroit “(b)(4)” facility noted potential routes of contamination of your processing environments, including but not limited to items from outside of the facility (including a rolling cart containing dirty dishes, trash cans, and U-boat carts) observed within the RTE produce cutting area without first being cleaned and sanitized, and employees coming into contact with the same door used by these outside items without washing or sanitizing their hands within the RTE cutting area.

Additionally, the inspection of your Detroit “(b)(4)” facility revealed your written sanitation preventive control procedures do not cover sanitation of carts received from other DO&CO, Inc. facilities before they are moved into the RTE plating room. Also, in practice these carts are not routinely cleaned and sanitized during the day.

During the inspections of your New York facility and Detroit “(b)(4)” facility, insanitary employee practices and conditions were observed showing you were not adequately following your written Sanitation Control procedures.

Specifically, your “(b)(4)” and “(b)(4)” written procedures were observed not being followed during the inspection of your New York facility, including but not limited to:

  • A gloved employee touching garbage in a trash bin and immediately handling RTE vegetables without changing gloves or washing/sanitizing hands on June 10, 2025. Your procedures state that disposable gloves must be changed after handling or touching non-food contact areas or things (i.e., garbage, refuse, pallets, cartons, boxes, etc.).
  • Lack of washing hands during employee glove changes observed throughout each day of the FDA inspection. Your procedures state (b)(4).
  • An employee using a paper towel that was in contact with a soiled conveyor belt to wipe RTE meal bowls on June 24, 2025, which does not ensure, per your procedures, that food and non-food contact surfaces are not contaminated by unclean surfaces.

Additionally, your “(b)(4)” and “(b)(4)” written procedures were observed not being followed during the inspection of your Detroit “(b)(4)” facility, including but not limited to:

  • An employee handling a pan of raw bacon for another employee then returning to handling RTE cucumber and tomato salad without washing or sanitizing their hands on August 8, 2025. Your procedure states (b)(4). 
  • Knives that were “wiped clean” and ready for use were observed placed in visibly dirty sanitizer water that was not monitored for sanitizer concentration. These knives were then used for cutting RTE produce on July 14, 2025 without further cleaning or disinfection by measured sanitizer concentration. Your procedures state (b)(4). Your procedures also stated (b)(4).

Also, the inspections of your Detroit “(b)(4)” and “(b)(4)” facilities revealed that your written environmental monitoring procedures lacked elements including but not limited to identification of the number of swabbing locations, timing and frequency for swab collection, analytical method(s) used, and the laboratory conducting the analysis, as required by 21 CFR 117.165(b)(3). Additionally, corrective action procedures for environmental monitoring results lacked procedures for evaluation of affected food to prevent entrance of adulterated food into commerce, as required by 21 CFR 117.150(a)(1)(ii) and 21 CFR 117.150(a)(2)(iii-iv).

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.

FDA’s analysis identified the following:
In your New York facility, ten (10) FDA environmental swabs were positive for L. monocytogenes during the 2025 inspection in areas in close proximity to food contact surfaces and in high-traffic areas, including, legs of a processing area table, floor surfaces within processing areas, floor surfaces beneath cooling units, a tilt skillet leg, and the wheels of rolling racks. This was not the first time that L. monocytogenes was found in environmental swabs collected at your New York facility. In 2024, FDA detected L. monocytogenes in thirty-four (34) environmental swabs, including three (3) direct food contact (zone (b)(4)) locations on a stainless-steel tray located between the Vegetable Wash Room and the Vegetable Cut Room, the surface of carrot and cucumber cutting boards in the Vegetable Cut Room, and condensate located under the AC unit #(b)(4) in the Vegetable Cut Room.

Whole genome sequence (WGS) analysis of the environmental isolates collected at your New York, Illinois, and Michigan facilities in 2024 and 2025 revealed twelve (12) strains of L. monocytogenes. Four (4) strains included isolates found in one facility in only one of the two years, five (5) strains were found in a single facility in both years (New York 132nd Street: 4 strains; Detroit “(b)(4)”: 1 strain), and three (3) strains were found in both years and in multiple facilities. One strain matched clinical isolates, indicating that this strain of Listeria causes human illness. We advised you of the importance of these WGS results on July 24, 2025.

The reoccurring presence of L. monocytogenes in your airline catering facilities demonstrates that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facilities. 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. Furthermore, as multiple strains were found across multiple facilities, a specific means of investigation into potential mechanisms of this (e.g., transfer of equipment, ingredients, personnel, suppliers, etc.) may be necessary.

In addition, in reviewing your (b)(4) facilities’ environmental monitoring records, we note that you have repeatedly found L. monocytogenes and Listeria spp. through your own testing. A review of the laboratory reports for your Detroit “(b)(4)” facility dated July 19, July 21, July 29, and July 31, 2025, found L. monocytogenes was recovered from multiple non-food-contact surfaces, including but not limited to the hot kitchen floor, a blast chiller drainage pipe in the cold kitchen, and a cooler floor and wall (where RTE bulk food is routinely stored), and Listeria spp. including L. ivanovii and L. innocua were recovered from non-food-contact surfaces within a cooler on July 21 and 28, 2025. Your documented response to the above L. monocytogenes findings included negative vector swabbing for three (3) days. A review of the laboratory reports for your Detroit “(b)(4)” facility found L. monocytogenes was recovered from nine (9) of your environmental samples collected between May 7, 2025 and August 18, 2025. All of these samples were collected from within the dish room used to clean and sanitize the dishware used for plating RTE food at the Detroit “(b)(4)” facility and dishes, utensils, and trolleys used for food service aboard aircrafts. The observed conditions and practices coupled with the recurring environmental findings of L. monocytogenes in your facilities demonstrate that you did not establish or implement adequate sanitation preventive controls and associated monitoring procedures to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of environmental pathogens such as L. monocytogenes.

We acknowledge that in response to the 2024 findings, you provided written responses to the issued FDA Form 483s as well as monthly status reports that described an overview of company-wide and facility-specific corrective actions, which included, but were not limited to, engaging with a third-party consultant to oversee and provide guidance on food safety practices and CAPAs, disposing of and purchasing new equipment, increasing the frequency of deep cleaning, establishing intensified employee training, updating your environmental monitoring program, sanitation, and temperature monitoring programs, evaluating traffic patterns, and updating your corrective action procedures.

We also acknowledge your written responses received for the 2025 inspections of your New York (August 11, 2025; September 12, 2025; October 9, 2025; November 7, 2025; December 8, 2025; January 11, 2026, February 9, 2026; and March 11, 2026) and your Detroit facilities (September 9, 2025; September 26, 2025; October 10, 2025; November 7, 2025; December 8, 2025; January 11, 2026; February 10, 2026; and March 9, 2026). These responses provided an overview of completed and planned corrective actions, including several newly established or updated written procedures. However, sufficient evidence has not been provided to date that demonstrates that these changes have been adequately implemented within your facilities.

You have not demonstrated your identification of the source(s), harborage sites, or eradication of L. monocytogenes within your facilities. Given the history of Listeria findings in your processing environment and most recent inspectional findings, we continue to be concerned about your ability to maintain a sanitary environment, implement an effective sanitation preventive control program, and take adequate corrective actions. We would encourage you to identify potential sources, harborage sites and routes of contamination in your processing environment and implement adequate corrective actions and necessary methods and controls based on your findings to ensure L. monocytogenes does not contaminate your environment or your RTE food products. A consultant with expertise in the control of L. monocytogenes may provide guidance in establishing such controls and procedures. We also encourage you to conduct necessary actions to verify that the actions you have taken are adequate as part of your food safety system. We remind you that environmental sampling is most effective at identifying pathogens when extensive sampling occurs several hours into production, because production activities may dislodge pathogens from harborage sites. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspections.

2. 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 of the Act, to comply with 21 CFR 117.135(a)(1).

Your hazard analyses for RTE airline meals manufactured at your Detroit “(b)(4)” facility and Detroit “(b)(4)” facility identified the hazard of Microbial Growth as requiring a preventive control at the (b)(4) step, stating “(b)(4)”. The facilities have written procedures titled Temperature Control for the Detroit “(b)(4)” facility and Temperature Controlled Areas for the Detroit “(b)(4)” facility that identify a purpose of ensuring all Time/Temperature Control for Safety (TCS) foods are maintained at temperatures that prevent microbial growth and toxin formation.

During the inspection of your Detroit “(b)(4)” facility, your written Temperature Control procedures, which state (b)(4), were observed not being followed for the coolers that are routinely used for overnight storage of RTE foods prior to dispatch to your Detroit “(b)(4)” facility for (b)(4), including:

  • Records showing lack of any overnight cooler temperature monitoring for all dates reviewed in May and June 2025 (exceeds four (4) hour interval per potential deviation criteria).
  • Records showing lack of any documented temperature monitoring of a produce cooler on May 17 and 18, 2025.
  • Records showing fewer than two (2) temperature checks per shift (there are two (2) shifts per day). Your CCP2 Temperature Control Form shows monitoring of cooler temperatures (b)(4) times a day, which was routinely noted in records reviewed for May and June 2025.

During the inspection of your Detroit “(b)(4)” facility, your written Temperature Controlled Areas procedures, which state the same monitoring frequency and deviation criteria above, were observed not being followed for the coolers that are routinely used for RTE meal storage, including:

  • Records showed a cooler temperature of (b)(4)F at (b)(4)PM on June 22, 2025, with the next cooler temperature check the next morning on June 23, 2025, at (b)(4)AM measuring (b)(4)F. Product within the cooler was documented at (b)(4)F (omelet) and (b)(4)F (yoghurt). Corrective actions were documented as moving product to another cooler and chilling with dry ice, but there was no product assessment conducted prior to release. This timeframe exceeds the four (4) hour deviation criteria and does not follow the written corrective action procedures which state that if TCS food exceeds 41F for more than four (4) hours it is to be discarded. 
  • Records showing fewer than two (2) temperature checks per shift (there are two (2) shifts per day). Your CCP2 Temperature Control Form shows monitoring of cooler temperatures (b)(4) times a day, which was routinely noted in records reviewed for June 2025.
  • Use of an infrared thermometer pointed at the upper half of the cooler wall observed to measure a lower temperature than the FDA thermometer at the time. Within a cooler, an employee measured a temperature of (b)(4)F while the FDA calibrated thermometer measured an air temperature of 43.5F.

We again acknowledge your written responses received for your 2025 Detroit facilities inspections. Similar to your monthly status reports provided between the January 2025 regulatory meeting and the initiation of the follow-up inspections, these responses continued to provide an overview of completed and planned corrective actions. We will verify the effectiveness of the implementation of your corrective actions and your ability to maintain a sanitary environment during our next inspection.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

3. You did not maintain your plant in a clean and sanitary condition, to comply with 21 CFR 117.35(a), as evidenced by the confirmation of nine (9) environmental samples positive for L. monocytogenes within the dishwashing room of your Detroit “(b)(4)” facility, which is the dishwashing facility for your “(b)(4)” facility (and “(b)(4)” when needed).

We acknowledge your update within the September 9, 2025 and October 10, 2025, consolidated responses for your Detroit facilities that your “(b)(4)” facility no longer manufactures, processes, packs, or holds food and the cancellation of that facility’s FDA Food Facility Registration on September 16, 2025. However, FDA remains concerned with the dishwashing environment of that facility and its risk of contamination of items for use in your other DO&CO, Inc. facilities, including food-contact surfaces and equipment/utensils used on aircrafts.

We also have the following comment:

FDA has also found non-pathogenic Listeria spp. including L. innocua, L. seeligeri, and L. welshimeri, in the processing environments of (b)(4) of your facilities in 2024 and within your New York facility in 2025. 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, which, as noted above, has been found in your facilities.

This letter is not intended to be an all-inclusive list of violations that may exist at your facilities 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 and 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 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.

Please send your reply via email to: HFP-OCE-EmergingIssues@fda.hhs.gov, copying Lauren Sexton, Compliance Officer, at Lauren.Sexton@fda.hhs.gov. If you have any questions regarding any issues in this letter, please contact Lauren Sexton, Compliance Officer, via email at Lauren.Sexton@fda.hhs.gov. Please include CMS #717773 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Priya Rathnam
Office Director
Office of Compliance Intervention and Consultation
Office of Compliance and Enforcement
Human Foods Program

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