- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Shao Song (Kevin) Chen
Recipient TitlePresident and Co-Owner
- New 88 Japanese Food Trading Inc
3305 Farrington Street
Flushing, NY 11354-2820
- Issuing Office:
- Division of Human and Animal Food Operations East I
CMS # 592644
Dear Messrs. Chen:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility and importer establishment, New 88 Japanese Food Trading Inc. located at 3305 Farrington Street, Flushing, NY 11354-2820, on August 13, 15, 19, 27, and September 6, 2019. During our inspection, we collected environmental samples (i.e., swabs) from various areas in your processing facility, including 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 ready-to-eat (RTE) tuna loins and imported, refrigerated tuna 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 (the Hazards Guide) 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. You provided responses to the L. monocytogenes positive findings via email on August 28, September 2, and September 17, 2019. In addition, you provided a response to the FDA-483 via email on September 27, 2019. Your responses indicate that you have cleaned your facility, established new procedures for sanitation and environmental monitoring, performed environmental swabbing, and revised your HACCP plan and other HACCP-related documents. We have reviewed the documentation and continue to have serious concerns with your current HACCP programs 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 INV1117726 collected on August 13, 2019, from various areas in your processing facility, including areas that are near food and food-contact surfaces, confirmed that ten (10) of the eighty (80) environmental swabs collected were positive for Listeria monocytogenes and one (1) additional swab was positive for non-pathogenic L. innocua.
Three (3) of the swabs that were positive for L. monocytogenes were collected from the following food-contact surfaces:
• The edge of the upper level of a table (swab # 17) that your firm was using to store unpackaged RTE tuna loins that were exposed to the processing environment;
• The black rubber strips (swab # 26) mounted in the middle of the swinging doors that lead from your processing cooler to your storage cooler. Your firm was observed to push a table with unpackaged, RTE tuna loins exposed to the processing environment through these doors. The RTE tuna loins were observed to make direct contact with the black rubber strips; and
• The top surface of a cutting board (swab # 38) that your firm reported was used to cut RTE tuna loins prior to sampling.
Whole genome sequencing (WGS) analysis was conducted on the ten (10) swabs obtained from INV1117726 that were positive for L. monocytogenes. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. This analysis found two (2) different strains of L. monocytogenes in your facility. Both strains were found on food-contact surfaces (Zone 1), and one (1) of the strains was also found in Zones 2, 3, and 4, indicating cross-contamination in your facility.
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. 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 September 27, 2019 response describes intensified environmental sampling being conducted, updating your sanitation procedures, and revising an environmental monitoring program. We will verify the adequacy of your corrective actions during a future inspection.
Your significant deviations are as follows:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 117, Subpart B, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B:
A. Design, material, and workmanship of equipment and utensils makes them adequately cleanable (21 CFR 117.40(a)). FDA investigators observed grooves on a plastic cutting board that did not allow for adequate cleaning and sanitizing. Your firm stated during our inspection that this cutting board was used earlier in the day to cut RTE tuna loins.
B. Conducting food manufacturing, processing, packing, and holding under conditions and controls to minimize the potential for the contamination of food (21 CFR 117.80(c)(2)). FDA investigators observed:
- Apparent moldy stains on various surfaces in the processing cooler, including on a folding table, the swinging doors that lead from your processing cooler into the storage cooler, and various other locations in your processing cooler. RTE tuna loins, staged on a table, were observed to make direct contact with these black rubber strips when the employees of your firm pushed the table through the these swinging doors and into your storage cooler.
- Apparent grease on the handle of hoses used for cleaning your processing cooler.
C. Taking effective measures to protect finished food from contamination (21 CFR 117.80(c)(6)). FDA investigators observed:
- Condensation from an air-conditioner dripping onto RTE tuna loins that were being stored on a table.
- Detergent and water sprayed from a high-pressure hose splashing from the floor to a bucket of uncovered ice and two boxes of uncovered striped bass.
D. Excluding pests (21 CFR 117.35(c)). FDA investigators observed:
- One mouse in the ambient storage area, approximately 3-5 houseflies in the processing cooler, and a spider web near the entrance to the processing cooler.
- The gate door of your facility being left open and the plastic curtain leading to the processing cooler missing one strip.
Additionally, you must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records required for the processing of RTE tuna loins that we observed on August 19, 2019.
We have reviewed the corrections identified in your responses and determined that not all of them appear to be adequate. Specifically, your root cause analysis and corrective action described in your response to address the condensation from the air conditioning system that was observed to drip onto tuna loins does not appear appropriate. Your root cause analysis determined that “condensation was not wiped off immediately,” and your corrective action is to hang a squeegee in the designated location and to use a disposable paper towel to wipe off condensation. This correction does not address protecting food contact surfaces and product from dripping condensation. It was noted during the close-out of the inspection that your firm moved the staging table to the middle of the production room, so it is no longer below the AC unit, and your solution to the condensation problem was to turn on both units. Please clarify regarding how you are addressing condensation and provide an update on the status of this correction.
Additionally, your response to the detergent and water that was observed splashing from the floor to the uncovered ice and uncovered striped bass was to replace all hose nozzles. It is not clear how replacing the nozzle will address the observation. Also, continued use of high-pressure hoses does not appear to be consistent with your “Sanitation Handling Techniques, Personal Hygiene Practice and Color Coding Program” procedure which indicates that “(b)(4)” and “(b)(4).” 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.
Your response includes a new sanitation monitoring form; however, it lacks actual monitoring records.
2. You must implement an affirmative step which ensures that the fish or fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the refrigerated tuna that you imported from (b)(4).
Your response includes a certificate from the (b)(4) Department of Agriculture certifying that the fresh chilled tuna manufactured by (b)(4) is “manufactured under the HACCP system for assuring food safety.” However, to comply with 21 CFR 123.12(a)(2)(ii)(B), the certificate must specifically certify the fish or fishery product was processed in accordance with the requirements in 21 CFR Part 123.
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 revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 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.
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, seizure and injunction. Additionally, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act, 21 U.S.C. § 381(a), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to importer establishments that are not in compliance with the seafood HACCP regulation is Import Alert # 16-119, Detention Without Physical Examination of Fish and Fishery Products for Importer and Foreign Processor (Manuf) Combinations. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
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 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.
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.
Your written reply should be sent to the U.S. Food and Drug Administration, Attention: Timothy M. Glod, Compliance Officer, 1 Montvale Avenue, 4th Floor, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Glod at (781) 587-7473 or by email at Timothy.Glod@fda.hhs.gov.
Program Division Director
Office of Human and Animal Food Operations
East – Division 1