Inspections, Compliance, Enforcement, and Criminal Investigations
Western United Fish Company, Inc. 16-May-08
Department of Health and Human Services
Public Health Service
May 16, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-15
Alex-Hung H. Tran, President
Western United Fish Company, Inc.
94118th Avenue South, Suite 1
Seattle, Washington 98108
Dear Mr. Tran:
We inspected your seafood processing facility, located at 9411 8th Avenue South Seattle, Washington, on March 11 and 12, 2008. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 scombroid species products, such as Yellowfin tuna, Bigeye tuna, Albacore tuna,Mahi-Mahi, swordfish, Wahoo, and escolar are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have a HACCP plan that lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for "SCOMBROID SPECIES in Fresh H&G, Fillet or Loin Form" lists monitoring procedures and a frequency at the refrigerated storage CCP that is, not adequate to control histamines. Specifically, the HACCP plan for "SCOMBROID SPECIES in Fresh H&G, Fillet or Loin Form" to control the hazard of histamines lists monitoring the temperature of the cooler by a, "Visual Wall Temperature Thermometer Check" at a frequency of [redacted] times per day, rather than continuous monitoring of the storage temperature with a continuous temperature monitoring and recording device, such as a recording thermometer or a digital time/temperature data logger.
Because histamine formation is a significant hazard at the Critical Control Point (CCP) of storage and development can be accelerated by small increments of temperature abuse, visually monitoring the cooler temperature [redacted] times per day is not adequate to control the hazard. Therefore, a continuous temperature monitoring and recording device is necessary in order for your firm to assess any temperature deviations that may occur during any 24 hour period to control the hazard of histamine formation in refrigerated storage of scombroid species.
2. Because you chose to include a corrective action plan. in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b): However, your corrective action plans for "SCOMBROID SPECIES in Fresh H&G, Fillet or Loin Form" at the "Receiving" and "Storage" Critical Control Points to control histamine formation are not appropriate. The current monitoring procedures at receiving, checking internal temperatures or adequacy of ice, cannot provide the means for "evaluating based on time/temperature exposure" as listed in the HACCP plan-as a corrective action at the "Receiving" CCP. Therefore, the listed correction action for "Receiving" cannot be adequately implemented.
In addition to the corrective action for the "Storage" CCP, adding ice to the affected product, we recommend including the following alternative corrective actions to the HACCP plan: destroy the product; or divert the product to a non-food use. You also have the corrective action alternative at "Receiving" and "Storage" or performing histamine analysis on the lot of affected product by analyzing the entire lot if less than 60 fish. If any fish are found with histamine at 50 ppm or greater, the lot should,be destroyed or diverted to a non-food use.
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.
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 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
Copy of FDA 483
cc: WSDA, with disclosure statement