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WARNING LETTER

Onofrio's Fresh Cut, Inc. MARCS-CMS 618502 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Richard A. Onofrio
Recipient Title
Owner/President
Onofrio's Fresh Cut, Inc.

222 Forbes Ave.
New Haven, CT 06512
United States

Issuing Office:
Office of Human and Animal Food Operations - East Division 1

United States


WARNING LETTER

CMS 618502

January 10, 2022


Dear Mr. Onofrio:

The United States Food and Drug Administration (FDA) inspected your produce processing facility located at 222 Forbes Ave., New Haven, CT 06512 from July 13, 2021 through July 29, 2021. During our inspection, 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). Additionally, FDA collected environmental samples 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. FDA’s inspection resulted in an issuance of a FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found at your facility.

Based on FDA’s inspectional findings and the analytical results for the environmental samples, we have determined the RTE fresh-cut produce (e.g., onions, peppers, celery, broccoli, cantaloupe, watermelon, and kiwi) processed in your facility is 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 it was prepared, packed, or held under insanitary conditions whereby it 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 part 117) is prohibited by section 301(uu) of the Act [21 USC 331(uu)]. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.

We received your responses sent via email on August 12, 2021, and August 17, 2021, which included a summary of corrective actions you have taken or plan to take. After reviewing the inspectional findings and your responses to the observations listed in the FDA-483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your responses below.

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

1. You did not appropriately evaluate contamination with environmental pathogens, such as L. monocytogenes, to determine whether it is a hazard requiring a preventive control in your fresh-cut produce, in accordance with 21 CFR § 117.130(a)(1). Your hazard analysis considered pathogen contamination at the cutting and assembling processing steps but determined that a preventive control was not necessary due to CGMPs/SSOPs and a prior wash step. However, your RTE fresh-cut produce is exposed to the environment during cutting and assembly and does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Thus, environmental pathogens are a hazard likely to occur in the absence of preventive controls (i.e., sanitation controls).

Furthermore, as evidenced by the following analytical results, your sanitation controls are not adequate 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, as required by 21 CFR § 117.135(c)(3).

FDA’s current inspection included the collection of environmental swabs on July 13, 2021, during the production of RTE fruits and vegetables; four (4) of seventy-one (71) swabs were confirmed positive for L. monocytogenes. The positive findings include a mixing room floor drain adjacent to a table where RTE celery was being cut, forklift wheels, a wheel on a rolling cart holding shrimp and seafood salad ingredients, and a packing room broom handle. This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2019, FDA detected L. monocytogenes in four (4) environmental swabs, including those from areas adjacent to food-contact areas. In addition, also in 2019, Listeria innocua, a non-pathogenic Listeria species, was confirmed in three (3) swabs, including a broom handle hanging in the packing room, and food contact surfaces in the mixing room (i.e., cutting board where RTE zucchini was being cut and the tabletop surface where zucchini and celery were being cut). Further, Listeria welshimeri, a non-pathogenic Listeria species, was confirmed in (2) swabs: a floor leading from the (b)(4) room into the (b)(4) room and a table in the vegetable cutting room used to hold totes of vegetables. The presence of Listeria species such as Listeria innocua and L. welshimeri suggests that conditions also are suitable for survival and/or growth of L. monocytogenes, which, as noted above, has been found in your facility.

Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the environmental samples collected at your facility during our 2021 and 2019 inspections represent four (4) unique strains of L. monocytogenes. Two different strains were found during the 2019 inspection, and two additional different strains were found during the 2021 inspection. Three (3) environmental swabs collected during the 2021 inspection were collected from different areas in your facility and are the same strain of L. monocytogenes. We advised you of the importance of these WGS results via a conference call on September 28, 2021.

The reoccurring presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. 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 areas of the food processing plant where this organism is able to survive, and to take such 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.

Your August 17, 2021 response stated that you plan to reassess your “Produce HACCP Plan” to identify a “preventative control program” at the “Cut Produce” and “Assemble” processing steps to control the potential biological hazard of pathogen contamination. You did not submit your revised plan for agency review to date.

You voluntarily destroyed all products produced between the cleaning performed before and after our environmental samples were taken on July 13, 2021. In addition, your written response received August 12, 2021, outlined the corrective actions you plan to take and those you have implemented, including conducting a root cause analysis (in which you identified the floor drains within your facility as a likely harborage area for L. monocytogenes), extensive reconditioning of your drains, new cleaning and sanitizing procedures regarding your drains, retraining sanitation employees, changing sanitizing chemicals used for the floors and drains, reconditioning the floors within the manufacturing area, replacement of brooms and squeegees, and retesting areas that were found positive by the FDA. Further, your response noted that your facility plans to continue to gather information over the next 3-6 months to confirm that you have located and eradicated the harborage site(s) or modify and implement additional corrective and preventative measures. However, you have not provided any additional information regarding your investigation of the source of the L. monocytogenes to show that you have located and eradicated the harborage site(s) or provided sanitation records to show that you have implemented your corrective actions.

With the history of FDA’s findings of L. monocytogenes in your facility, effective environmental sampling conducted as verification of corrective actions should involve a comprehensive and extensive survey of your facility that includes samples collected several hours into production in greater quantity and more locations than were taken in your monitoring program. Furthermore, we encourage you to continue to evaluate your facility to ensure you have identified all areas where L. monocytogenes is likely to be found. 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. You should continue to implement the necessary methods and controls to ensure foodborne pathogens do not contaminate your RTE food products. Your record keeping will be critical to demonstrate your implementation of these corrective actions consistently over time. 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 identify and implement an appropriate preventive control 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, as required by 21 CFR § 117.135(a)(1). Specifically, you did not establish supply-chain controls for pathogens such as L. monocytogenes, pathogenic E. coli, and Salmonella at the receiving step for incoming produce. Your hazard analysis indicated that pathogens will be controlled at a later wash step. However, your produce wash does not effectively destroy pathogens on the whole produce, as indicated by an email on July 20, 2021, from a representative of your supplier of (b)(4) sanitizer, which is used in your produce wash. The email indicated that “When the product is used as veggie wash, the product is not making a kill claim. It is only claiming microbial intervention.” Therefore, you should have identified pathogens in produce at the receiving step as a hazard requiring a supply-chain-applied control and implemented a risk-based-supply-chain program for those ingredients pursuant to 21 CFR § 117.405(a)(1). Further, you did not use approved suppliers for produce or conduct supplier verification activities, as required by 21 CFR § 117.410.

Your August 17, 2021 response discussed actions your facility plans to take to address these deficiencies, such as reassessment of your “Produce HACCP Plan” to identify a supplier approval program as a “preventative control program” to control biological hazards at the receiving step. However, you did not submit your revised supply-chain program. We will verify the effectiveness of your corrective actions during our next inspection.

Current Good Manufacturing Practice (Subpart B):

1. Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food or food-contact surfaces, as required by 21 CFR § 117.20(b)(4). Specifically, on July 14, 2021, FDA investigators observed the following conditions:

• Condensate droplets on the underside of the refrigeration unit above a blue bin containing RTE baby carrots and above the (b)(4) conveyor in the vegetable wash room.

• Condensate droplets on the ceiling throughout the vegetable mixing room directly above uncovered RTE vegetables (including peppers, onions, and zucchini) and food-contact surfaces.

Your August 17, 2021 response stated that the condensation was caused by various mechanical issues with your refrigeration units. Your response also stated that the refrigeration units have been repaired, and employees have been trained to identify and correct condensation issues. We will assess the adequacy of your corrective actions during our next inspection.

2. Your plant did not have adequate sanitary facilities and accommodations, as your plumbing was not adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition, as required by 21 CFR § 117.37(b)(3). Specifically, on July 13, 2021, the hand wash sink located at the end of the (b)(4) conveyor in the vegetable wash room was leaking a large amount of water onto the floor while in use. Further, on July 14, 2021, a small amount of water was leaking from underneath the same hand wash sink (near the pedals) onto the floor. You explained that the leak at the hand sink was due to a clogged drain.

Your August 17, 2021 response stated that the hand wash sink was repaired. We will assess the adequacy of your corrective action during our next inspection.

3. 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). Specifically, on July 15, 2021, during the pre-operational inspection, the cutting board in the vegetable cutting room failed inspection and was recleaned. During recleaning, an employee was observed placing a bucket containing soap solution, which was previously located on the production room floor, on top of the cutting board during the wash step. Additionally, the same employee placed the water hose spray nozzle that was previously on the production room floor onto the discharge side of the (b)(4) conveyor.

Your August 17, 2021 response stated that pre-operation inspection employees and line workers have been retrained on how to conduct sanitation of equipment so that recontamination of food-contact surfaces does not occur from buckets and hoses. We will assess the adequacy of your corrective actions during our next inspection.

4. You did not clean non-food-contact surfaces of equipment in a manner and as frequently as necessary to protect against contamination of food, as required by 21 CFR § 117.35(e). Specifically, on July 14, 2021, an employee was observed rinsing the floor and cutting boards with a water hose in the mixing room. Overspray from the hose was in close proximity to two partially covered bins with RTE cut celery.

Your August 17, 2021 response stated that employees have been trained on the prevention of overspray, proper use of sanitation hoses, and stands used to hold totes. We will assess the adequacy of your corrective actions during our next inspection.

5. You did not take adequate precautions to ensure that production procedures do not contribute to contamination, as required by 21 CFR § 117.80(a)(4). Specifically, on July 13, 2021, while employees were processing RTE onions in the (b)(4) room, the (b)(4) line was stretched across the production room floor and then draped over a bin containing RTE processed onions.

Your August 17, 2021 response stated that employees have been trained in sanitation procedures such as proper use of the (b)(4) line. We will assess the adequacy of your corrective actions during our next inspection.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their reoccurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, administrative action for suspension of food facility registration if criteria and conditions warrant.

In addition to the violations described above, we offer the following comment regarding documentation activities associated with your environmental monitoring program. When swabs tested positive for Listeria spp. on September 3, and October 14, 2020, you told our investigators that you investigated and took corrective actions, but you did not document these activities.

Section 743 of the FDCA (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection, assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Please notify FDA in writing within 15 working days of the receipt of this letter of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the reoccurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the timeframe within which you will do so.

Please send your reply to the Food and Drug Administration, Attention: W. Martin Rennells, Compliance Officer, One Winner’s Circle, Suite 140, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Mr. Rennells at 518-453-2314 x1038 or willliam.rennells@fda.hhs.gov.

Sincerely,
/S/

Ronald Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1

 
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