- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Dian Yan Lin
- AB Seafood Trading Inc
31-29 Higgins Street
Flushing, NY 11354-2503
- Issuing Office:
- Division of Human and Animal Food Operations East I
158-15 Liberty Avenue
Jamaica, NY 11433
July 16, 2019
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, AB Seafood Trading, Inc. located at 31-29 Higgins Street, Flushing, NY 11354-2503 on May 15th, 17th, & 24th, 2019. That inspection revealed 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). Accordingly, your refrigerated and raw, ready-to-eat seafood products including tuna, Spanish mackerel, salmon, sea bass, trout, fluke, amberjack and vacuum packaged yellowtail (Hamachi) are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may be rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for raw, refrigerated, salmon, sea bass, trout, fluke, and mackerel intended to be consumed raw, ready-to-eat without further cooking does not list the food safety hazard of parasites.
2. 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 plan for refrigerated, raw, ready-to-eat, vacuum packed yellowtail (Hamachi) lists a critical limit of: "Temperature remains below (b)(4)°F or (b)(4) which maintain internal temperature of product (b)(4)°F or (b)(4)” at the receiving critical control point that does not ensure the control of Clostridium botulinum toxin formation hazard. In practice you receive this product with (b)(4) and Time-Temperature Indicators (TTI’s) (b)(4) yellowtail (Hamachi) and as such FDA currently recommends the following:
- TTI attachment and activation;
- Adequate quantity of cooling media that remain frozen to have maintained product at 40° F (4.4° C) or below throughout transit;
- The internal temperature of the product at the time of delivery is 40° F (4.4° C) or below.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of “(b)(4) the data will be (b)(4) recorded. The operation manager are responsible to check the data (b)(4)” listed at the Refrigerated Storage Critical Control Point (CCP) to control the following hazards: pathogen growth and toxin formation for your raw, ready-to-eat salmon, sea bass, trout, fluke, mackerel, tuna, and vacuum packaged yellowtail (Hamachi); scombrotoxin (histamine) formation for your raw, ready-to-eat tuna, mackerel, and vacuum packaged yellowtail (Hamachi); and Clostridium botulinum toxin formation for your refrigerated, raw, ready-to-eat, vacuum packed yellowtail (Hamachi). In practice you do not monitor the recorded data for your continuous time and temperature monitoring device used to monitor the cooler temperature for cooler (b)(4) where raw, ready-to-eat fish is stored and for cooler (b)(4) where raw, ready-to-eat tuna and salmon are processed and stored. This is further evident by a review of your continuous temperature-recording monitoring records by our investigators during the current inspection that revealed that the critical limit, at the Refrigerated Storage CCP, of “Maximum cooler temperature (b)(4)° F”, was not always met and no corrective action was taken.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 117, to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, protection of food, food packaging material, and food contact surfaces from adulteration and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 117 as evidenced by:
- On 05/17/19, the (b)(4) cutting board used to cut raw, ready-to eat tuna loins and raw, ready-to-eat salmon was observed to have deep scoring allowing for areas that cannot be adequately cleaned and sanitized.
- On 05/17/19, your manager tested your sanitizing solution used to sanitize food contact surfaces such as the cutting boards and knifes used to process raw, ready-to-eat tuna and salmon. The test strip resulted in no color change, indicating a measure of (b)(4)ppm or less. In addition, a review of your records for March, April, and May, document that you always achieved a concentration of (b)(4)ppm: however, and your manager explained that no testing was done and that it was assumed that concentration was always (b)(4)ppm.
- On 5/17/19, an accumulation of stagnant liquid was noted on the cracked floor inside the processing room where raw, ready-to-eat fish is processed and packaged as well as inside the walk-in cooler.
- On 5/17/19, one of your employees touched multiple surfaces including but not limited to a marker used to write on the boxes, handle of the walk-in cooler, table surface below the office window, and surface of the boxes. The same employee then handled raw, ready-to-eat tuna with the same gloved hands. Another employee was observed touching the rim of the garbage can, and the trolley handle, and then handled raw, ready-to-eat tuna without sanitizing or changing his gloves.
- On 5/17/19, two pieces of raw, ready-to-eat salmon were stored directly on top of the outside surface of two Styrofoam boxes and one piece of raw ready-to-eat salmon was stored on top of a live soft-shell crab carton box inside the processing room. The Styrofoam boxes with the salmon on top were stored directly on the processing room floor. Neither the top of the Styrofoam box or the top of the carton box were cleaned. Raw, ready-to-eat salmon fillets were packaged inside these Styrofoam boxes by placing a contact sheet paper in between each fillet. The contact paper was observed stored directly on top of a soiled cooler box.
- During the current inspection your garage door leading to your dry storage area and where raw, ready-to-eat seafood is staged for walk-in customers, was kept open throughout the entirety of this inspection. Birds and apparent bird droppings were observed inside your firm.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the seafood HAACP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10601. If you have questions regarding any issues in this letter, please contact Michael R. Dominick at 914-682-2826 or email at Michael.Dominick@fda.hhs.gov.
Program Division Director
Office of Human and Animal Food Operations -
East Division 1