- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Markus Draxler
- CATSMO LLC
25 Myers Road
Wallkill, NY 12589-3516
- Issuing Office:
- Office of Human and Animal Food Operations East Division 1
CMS # 599871
March 25, 2020
Dear Mr. Draxler:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) seafood processing facility, Catsmo LLC., located at 25 Myers Road, Wallkill, NY 12589-3516, on November 18, 2019 through December 12, 2019. During our inspection, we collected environmental samples (i.e., swabs) from various areas in your processing facility, including food-contact surfaces and areas that are near food and food-contact surfaces. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation [Title 21, Code of Federal Regulations, Part 123 (21 CFR 123)].
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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Based on our inspectional results, including review of your HACCP plan and environmental testing, we have determined that your RTE cold smoked seafood products are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. Subsequently we received your firm’s response dated January 10, 2020, which included a description of corrective actions taken by your firm. We have reviewed your response and continue to have serious concerns as further described in this letter.
Presence of L. monocytogenes
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, 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 laboratory analysis of the environmental sample INV1096999 collected on November 19, 2019, during the processing of RTE cold smoked salmon, confirmed five (5) of the seventy-eight (78) environmental swabs collected were positive for L. monocytogenes. Of the positive findings, three (3) swabs were collected from food-contact surfaces which included the scissors/cutting board used to trim RTE cold smoked salmon; the surface of conveyor belt at the start of the skinner used to skin the RTE cold smoked salmon; and the slicer used to cut the RTE cold smoked salmon.
Whole genome sequencing (WGS) was conducted on five (5) L. monocytogenes isolates obtained from the FDA environmental sample collected on November 19, 2019. The current WGS analysis determined that the isolates derived from the samples collected at your facility during our most recent inspection represent a single strain of L. monocytogenes. These isolates are also genetically identical to one (1) environmental isolate collected in 2019 from a New York facility and one (1) clinical isolate. We advised you of those WGS results via a conference call on January 10, 2020.
Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Appropriate control of L. monocytogenes in a food processing environment requires expert knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to eliminate this pathogen. It is essential to identify areas in your food processing plant where this organism is able to grow and survive and to take corrective actions to eradicate the organism by rendering these areas unable to support the growth and survival of the organism. Once it 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 is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.
Your response outlines the corrective actions you have taken and plan to take in response to our findings regarding the presence of L. monocytogenes in your plant. After you were made aware of our environmental findings, you conducted a voluntary recall of all product produced on the day we collected environmental swabs, voluntarily ceased manufacturing operations from December 6, 2019 through December 16, 2019 to conduct corrective actions, and replaced all equipment, tools, and cleaning supplies from which we isolated L. monocytogenes. Additionally, your response indicates that you have cleaned your facility, performed environmental swabbing, hired consultants, and are in the process of reviewing and revising your programs which included your SOPs, SSOPs, Prerequisite programs, GMPs, HACCP plans, environmental monitoring, product testing, and hold and release protocol. However, you have not submitted copies of your updated environmental monitoring procedure and any other documentation related to your corrective actions. The adequacy of your firm’s implementation of these corrective actions and your firm’s ability to effectively control the presence of the environmental pathogen L. monocytogenes will be assessed during our next inspection.
Your significant deviations are as follows:
1. You must monitor conditions and practices during processing with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), that are appropriate to your plant and the food being processed and relate to one of the areas specified in 21 CFR 123.11(b)(1)-(8), to comply with 21 CFR 123.11(b). However, your firm did not monitor the following conditions and practices with sufficient frequency to ensure compliance with CGMPs:
A. You did not monitor conditions and practices with sufficient frequency to ensure that all plant equipment and utensils are so designed and of such material and workmanship as to be adequately cleaned and adequately maintained to protect against allergen cross-contact and contamination, as required by 21 CFR 117.40(a). [This relates to the condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments (21 CFR 123.11(b)(2))]. Specifically, FDA investigators observed the following:
i. A cutting board in the smoked salmon slicing and packing room used to cut and trim RTE cold smoked salmon fillets was observed to be heavily gouged which does not allow for adequate cleaning and sanitizing.
ii. Worn edges with a buildup of black residue were observed on plastic trays used to hold RTE salmon fillets during salting.
B. You did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination, as required by 21 CFR 117.80(c)(6). [This relates to prevention of cross-contamination from insanitary objects to food (21 CFR 123.11 (b)(3))]. Specifically, FDA investigators observed the following:
i. Cleaning operations were being performed in the salting room where several racks of exposed RTE salmon fillets were being staged for salting. An employee was using a high-pressure water hose to spray the floor several feet away from the exposed rack of RTE salmon fillets. There was no separation of these activities in order to prevent cross contamination from aerosolized overspray.
ii. A high-pressure water hose with handle and nozzle head was used to rinse scissors, knives, and other utensils in between cutting and trimming RTE cold smoked salmon in the smoked salmon slicing and packaging room and was also used at the end of the production day to wash equipment, including food contact surfaces such as conveyor belt parts and blades to the slicer. An employee was observed handling the hose and nozzle and then touching various utensils and equipment during and after cleaning. Swab #148 collected from the nozzle of the hose was found positive for L. monocytogenes. In addition, this hose was observed to be used to rinse the scissors on which L. monocytogenes was identified.
C. You did not monitor conditions and practices with sufficient frequency to ensure that your plant is constructed in such a manner that condensate from fixtures, ducts and pipes does not contaminate food, food contact surfaces, or food-packing materials, as required by 21 CFR 117.20(b)(4). [This relates to protection of food, food packing material, and food contact surfaces from adulteration with condensate (21 CFR 123.11 (b)(5))]. Specifically, on November 19, 2019, FDA investigators observed condensation accumulating on the condenser unit fans on the ceiling of the brining room and dripping on and around white plastic trays used to salt and season RTE salmon fillets during brining. This is a repeat observation noted during previous inspections.
Your firm’s response includes descriptions of the corrective actions that you have taken, which include disposing and replacing all cutting boards; disposing of white plastic trays that are in poor condition; replacing the hose and hose handle where L. monocytogenes was found; retraining employees in proper water hose handling and usage; and performing repairs on your cooling units to address the condensate buildup with the long term corrective action of replacing your units. However, you did not provide any documentation, such as training records, to support your corrective action for the use of high-pressure water hoses during production. To prevent aerosols from contacting RTE food, food contact surfaces, and food packaging materials, FDA recommends avoiding the use of high-pressure water hoses during production in areas where RTE foods are exposed or after equipment has been cleaned and sanitized. You should note FDA considers salmon used to manufacture cold smoked salmon to be RTE from receipt to finished product since the cold smoke step is not a heat treatment intended to eliminate pathogens such as L. monocytogenes. In addition, we recommend that you monitor conditions with sufficient frequency to ensure employee practices prevent cross-contamination from over spray and that food, food packaging material, and food contact surfaces are protected from adulteration with condensate. We will verify the adequacy of these corrective actions during our next inspection.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your updated environmental monitoring program, sanitation programs, HACCP plans, completed monitoring records to demonstrate implementation, photographs of repairs to food processing equipment, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within fifteen (15) days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action without further notice including, without limitation, registration suspension, seizure and injunction.
In addition to the violations described above, we offer the following comment:
You must take an appropriate corrective action when a deviation from a critical limit occurs. Your laboratory analysis from a private laboratory for vacuum packaged cold smoked salmon revealed a water phase salt level of (b)(4) on October 9, 2018 and a water phase salt level of (b)(4) on May 9, 2018. Your critical limit at the Salting critical control point states “Minimum time in salt by salting chart to achieve + (b)(4) WPS”; however, review of your records indicate that you did not take any corrective action to address these results that do not meet the critical limit. In response to this finding, your firm’s January 10, 2020 response states, “After investigating, it turns out these results were related to Research & Development studies & testing,” and “A R&D stamp has been purchased to avoid any confusion with any out-of-spec results moving forward.” We strongly recommend that you are vigilant on the final disposition of your products to ensure products that will be distributed to consumers are in compliance with the Act and all applicable regulations.
Additionally, section 743 of the Act (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 and assessing and collecting re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). 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 re-inspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: Michael Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10605. If you have questions regarding any issues in this letter, please contact Mr. Dominick at 914-682-2826 ext. 20 or by email at email@example.com.
Program Division Director
Office of Human and Animal Food Operations
East – Division 1