WARNING LETTER

U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods MARCS-CMS 580946 — July 30, 2019

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

Recipient:: Recipient Name

Mr. Felix Endico and Mr. William Endico; Recipient Title

Owners; U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods; 300 N. MacQuesten Pkwy
Mount Vernon, NY 10550-1008
United States

Issuing Office:: Division of Human and Animal Food Operations East I; 158-15 Liberty Avenue
Jamaica, NY 11433
United States

WARNING LETTER
CMS # 580946

VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

July 30, 2019

Mr. Felix Endico, Owner
Mr. William Endico, Owner
U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods
300 N. MacQuesten Pkwy
Mount Vernon, NY 10550-1008

Dear Messrs. Endico:

The United States Food and Drug Administration (FDA) inspected your Ready-to-Eat (RTE) salads and prepared foods manufacturing facility located at 300 N. MacQuesten Pkwy, Mount Vernon, NY from February 11 through March 7, 2019. During our inspection of your facility, 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)] and the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123). Additionally, FDA collected environmental samples from various areas in your facility, including areas that are near food during processing operations and your food contact surfaces. FDA laboratory analyses 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 samples, we determined that your RTE products 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 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, B, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 USC § 331(uu)]. Lastly, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. You may find the Act and further information about 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 are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

We acknowledge your firm’s email response to the positive L. monocytogenes sample findings sent on March 1, 2019, and your responses to the FDA Form-483 (FDA-483) sent on March 27, 2019, with an additional response provided on May 1, 2019. Your responses included written summaries of corrective actions, sanitation and cleaning procedures, environmental swab and finished product testing results in response to the L. monocytogenes findings, an environmental monitoring program, training documentation, and other supporting documentation. However, we found your responses either inadequate or we did not have sufficient information to determine the adequacy of your corrective actions for the reasons further discussed below.

We found the following significant deviations:

Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117, Subpart C)

1. You are required to identify and implement preventive controls 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). In your food safety plan, you did not identify and implement a preventive
control for the food safety hazard of contamination of RTE products with an environmental pathogen, such as L. monocytogenes. As evidenced by environmental findings that indicate a strain 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).

FDA laboratory analysis of environmental sample #1089468 collected at your facility on February 11, 2019 revealed that four (4) of (b)(4) environmental swabs collected were positive for L. monocytogenes. Furthermore, 3 of 4 of these positive environmental swabs were found on the (b)(4) equipment. These positive results occurred in zone 2 non-food-contact surfaces in close proximity to food and food contact surfaces. We note that you stated to the FDA investigator that your firm received the (b)(4) equipment from another manufacturing facility. When FDA performed a Whole Genome Sequencing (WGS) analysis of the four (4) L. monocytogenes isolates, the L. monocytogenes isolates were found to be the same strain as isolates collected at the manufacturing facility that you obtained the equipment from. This further demonstrates that you lacked adequate sanitation procedures to prevent environmental pathogens such as L. monocytogenes from contaminating your processing environment [21 CFR 117.135(c)(3)].

These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow 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.

We acknowledge your March 1 and 27, and May 1, 2019 responses outlining the corrective actions you have taken or plan to take in response to the L. monocytogenes environmental sample findings. These corrective actions include cleaning and sanitizing your processing environment, providing a sanitation and cleaning procedure (i.e., sanitation preventive controls), developing a new policy to clean, sanitize, and environmentally swab new equipment, conducting environmental sampling, and conducting finished product testing for L. monocytogenes. At this time, we do not have enough information to verify that your methods and control(s) will effectively prevent L. monocytogenes from contaminating your processing environment and further contaminating finished products you may manufacture in the future. We will verify the adequacy of your corrective actions during a future inspection.

2. Your firm did not implement adequate written procedures for product testing and environmental monitoring, as required by 21 CFR 117.165(b). Specifically, during our inspection we observed that you did not have verification procedures for environmental monitoring of L. monocytogenes. We acknowledge that you have developed a written environmental monitoring program entitled “Environmental Monitoring for Sanitation Preventive Control Verification,” issued 3/21/2019 and provided in your March 27, 2019 response, to verify the effectiveness of sanitation to control environmental pathogens such as L. monocytogenes. However, we still do not have enough information to verify that you are appropriately implementing the environmental monitoring program. Therefore, at this time, we are unable to fully assess the adequacy of your corrective actions. We will verify the adequacy of these corrective actions and implementation of your environmental monitoring program during a future inspection.

3. Your allergen controls procedures did not include appropriate controls for protection of food from allergen cross-contact, as required by 21 CFR 117.135(c)(2). Your firm packages a variety of RTE food products, including products that contain ingredients with known allergens such as fish; however, your allergen control program does not identify fish (e.g., tuna) as an allergen manufactured in the facility. Furthermore, employees were observed hand-filling and packaging RTE Tuna Salad in 3.0 oz. cups/80 CT. Item: 300389 and then hand-filling and packaging egg salad on the (b)(4) without cleaning the equipment in between. Food matter was observed accumulated on and around the section of the machine where film is applied ((b)(4)) onto the “cups.”

We acknowledge your March 27 and May 1, 2019 responses that included documentation of training for preventing cross contamination on February 28, 2019, and a new sanitation standard operating procedure (SSOP) procedure for “cleaning” the (b)(4). However, as stated above, you do not have fish identified as an allergen manufactured in your facility. Additionally, the SSOP for “cleaning” the (b)(4) lacks sufficient detail as to how you will appropriately control allergen cross-contact. Furthermore, we have not received information as to whether the “Allergen Batch Scheduling Program” has been implemented or how you plan to control the allergen risk until the SSOP is fully implemented.

Supply-Chain Program (21 CFR 117, Subpart G)

1. You did not conduct and document appropriate supplier verification activities, as required by 21 CFR 117.415(a)(2). Your firm’s process for RTE Potato Salad lists ingredients that have known hazards requiring Supply Chain preventive controls such as bacterial survival of a lethal treatment and re-contamination with environmental pathogens for the black pepper ingredient. Your firm has a written SOP 2.4.4, entitled “Approved Supplier Program,” dated Oct 15, 2017, and a document entitled “Sally Sherman Foods Vendor Alpha Listing,” dated December 11, 2018, which is your firm’s approved supplier list. However, you do not have documentation that your firm conducted supplier verification activities for each supplier of the black pepper, which requires supply chain controls for the identified hazards.

We acknowledge your March 27, 2019 response where you state, “Black pepper receives an antimicrobial treatment by the supplier prior to shipment to Sally Sherman Food,” and that “We’ve received the FSVP confirmation letter on the black pepper supplier.” It appears you are relying on the foreign supplier verification program as your supplier verification activity. However, because you are the receiving facility and not an importer, you are required to conduct appropriate supplier verification activities as outlined under 21 CFR 117.415(a)(2).

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

1. Your cold storage unit used to store and hold food did not have a temperature device installed to show temperature accurately, as required by 21 CFR 117.40(e). (b)(4) continuous time-temperature recording device sensors located in (b)(4) were out-of-service from January 24 to February 14, 2019. During the most recent inspection, your firm was observed storing RTE food products, including Potato Salad Code C196, in (b)(4), and (b)(4).

Your March 27, 2019, response indicates that you are only monitoring the cooler temperature manually Monday – Friday. Your response does not indicate if you are monitoring the temperature when the facility is closed or on the weekends. Your response also does not discuss if food is stored in these coolers during those time periods. Additionally, your response does not include a timeframe for the complete implementation of your corrective actions. Therefore, we are unable to fully assess your promised corrective actions as we do not have enough information and consequently cannot verify the adequacy of the methods and controls you have or will implement. We will verify the adequacy of your corrective actions during a future inspection.

2. Your plant was not constructed and designed to facilitate maintenance and sanitary operations for food-production purposes, as required by 21 CFR 117.20(b). The FDA investigator observed the following conditions:

? The floor areas in various processing and packaging rooms were in a state of disrepair with small pits, grooves, and cracks in the masonry work.

? The potato peeler was noted as having pooled water on the floor underneath and around it. Furthermore, environmental swabs (sample 1089468) collected from the floor area adjacent to the (b)(4)(swab #80) and a floor surface between the potato salad basin and (b)(4) filler unit were found positive for L. monocytogenes. In addition, the floor area in front of the (b)(4) cutter (swab #30) was found positive for Listeria innocua and in front of the potato salad mixer unit #(b)(4)(swab #94) was found positive for Listeria innocua/welshimeri.

Your March 27 and May 1, 2019, responses do not provide sufficient information, such as when the floor repairs will be completed. We will verify the adequacy of these corrective actions during a future inspection.

3. As observed during the current inspection, your equipment and utensils were not designed and constructed in a manner that facilitates adequate maintenance and sanitary operations, as required by 21 CFR 117.35(a). The FDA investigator observed the potato peeler to be heavily corroded and with a thick accumulation of filth and built-up food residue. In addition, decaying potatoes were observed resting on top of the equipment in crevices. Although in your May 1, 2019, response you state that the potato cleaning procedure was updated on March 21, 2019 and employees were trained on April 9, 2019, you have not provided evidence of corrective action. We will verify the adequacy of these corrective actions during a future inspection.

4. Non-food-contact surfaces of equipment used in the operation of a food plant must be cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR 117.35(e). However, employees were observed using high pressure water hoses to spray floor areas in the RTE processing facility in close proximity and directly next to equipment and food contact surfaces.

We acknowledge your response provided on March 27, 2019, that included an updated SSOP for cleaning walls and floors without the use of high-pressure hoses and training provided to employees on prevention of cross contamination on February 28, 2019. We will assess the adequacy of your corrective actions during a future inspection.

5. Equipment and utensils must be designed, constructed, and used appropriately to avoid the adulteration with contaminated water, or any other contaminants, as required by 21 CFR 117.40(a)(2). Your firm moves ingredients throughout the RTE food facility in metal carts. These carts were observed to be wheeled through damp floor areas. The metal carts are then mechanically lifted, tilted, the contents poured into mixers where they are subsequently mixed and blended for the manufacture of RTE foods. It was observed that the outside of the carts were not cleaned before being lifted and tilted above the mixer.

We acknowledge your response provided March 27, 2019, that included a procedure for cleaning and sanitizing the stainless steel bins (e.g., metal carts). In addition, in your May 1, 2019 response, you stated that you have installed sanitizer spray stations for equipment at entrances of the processing room. We will assess the adequacy of your corrective actions during a future inspection.

Seafood HACCP (21 CFR Part 123)

In addition, we have also observed you manufacturing products “Krabmeat Salad” and “Tuna Salad” that are both subject to seafood HACCP regulations (21 CFR Part 123), and we observed the following significant deviations:

1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plans for “Krabmeat Salad” and “Tuna Salad,” both dated July 7, 2013, list a critical limit of "Cooler maintained at (b)(4). Defrost cycles of up to (b)(4) do not violate the C.L." The “(b)(4)” critical control point in your HACCP plan for “Krabmeat” salad, and the “(b)(4)” critical control point for finished product storage in your reduced oxygen packed (ROP) tuna salad HACCP plan are not adequate to control pathogen growth and toxin formation, including Clostridium botulinum (C. botulinum) and histamine formation for tuna salad. FDA recommends that "Defrost cycles of up to (b)(4) do not violate the C.L." be removed from the critical limit, as corrective actions should be taken when the cooler exceeds (b)(4).

In addition, in your May 1, 2019 response you stated that you have determined that histamine formation during the finish salad storage step is not a hazard reasonably likely to occur. However, the canned tuna is opened and exposed to your processing environment, thereby allowing possible recontamination with histamine-forming bacteria. Furthermore, the finished product could be time and temperature abused if not properly stored, thus allowing the formation of unsafe levels of histamine. Therefore, histamine formation should be identified as a hazard that is reasonably likely to occur in your tuna salad. Although you have made the decision that histamine formation is not reasonably likely to occur, your listed critical limit for your cooler to be (b)(4) to control pathogen growth and toxin formation at your “(b)(4)” critical control point for finished product storage would also control the hazard of histamine formation.

2. You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). Your firm did not follow the monitoring procedures/frequencies listed in your HACCP plans (e.g., food safety plans) for “Krabmeat Salad” and “Tuna Salad,” both dated July 7, 2013, at the identified critical control points. Specifically, you did not implement your listed monitoring procedure of “(b)(4)” for your “(b)(4)” temperature to control pathogen growth and toxin formation, including C. botulinum for tuna salad. This monitoring procedure is listed at the “(b)(4)” critical control point in your HACCP plan for “Krabmeat” salad and at the “(b)(4)” critical control point for finished product storage in your reduced oxygen packed (ROP) tuna salad HACCP plan. During a review of your firm’s records, it was observed that your time temperature recording device in your “(b)(4)” was continuously reading “770.2” and not generating correct continuous time and temperature records from January 24, 2019 through February 14, 2019.

We acknowledge your May 1, 2019 response, indicating that new temperature probes have been delivered, installed, and are functional. We will evaluate the adequacy of your corrective actions and implementation of your temperature monitoring during a future inspection.

(b)(3)(A)

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 ensuring your facility operates in compliance with the Act, CGMP regulations, the PC rule, the seafood HACCP regulations, and other applicable laws.

You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action without further notice, including without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Section 743 of the Act [21 USC 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 non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re- inspection-related costs.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Please send your reply to the Food and Drug Administration, Attention: W. Martin Rennells, Compliance Officer, One Winner’s Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Mr. Rennells at 518-453-2314 x 1038 or willliam.rennells@fda.hhs.gov.

Sincerely,
/S/

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

Cc: Mr. Marc C. Mazzarulli, Vice President, Operations
U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods
300 N. MacQuesten Pkwy
Mount Vernon, NY 10550-1008