Inspections, Compliance, Enforcement, and Criminal Investigations
Trident Seafoods, Inc. 25-Sep-08
Department of Health and Human Services
Public Health Service
September 25, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-34
Charles Bundrant, Chief Executive Officer
Trident Seafoods, Inc.
5303 Shilshole Avenue NW
Seattle, Washington 98107
Dear Mr. Bundrant:
We inspected your seafood processing facility, located at 229 Main Street, Sand Point, Alaska, on July 23, 24, and 25, 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, including the sanitation control procedures under 21 CFR 123.11, 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 frozen headed and gutted salmon and your frozen cooked crab products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered. injurious to health or contaminated with filth. 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:
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 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; condition and cleanliness of food contact surfaces, including utensils, gloves; and outer garments; prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; and protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate; and other chemical, physical, and biological contaminants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced, for example, by:
1. Failure to protect the safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice as follows:
a. Your potable water lines lack back flow prevention on hoses that were found to be submerged in containers or areas of non-potable water such as a hand sanitizing tank, a tote filled with cod fish and water, a rain gear rinse barrel, and standing water on a process area floor.
b. The make-up water reservoirs for your ice making equipment contained rust and debris; which had entered the reservoirs due to loosely fitting lids
This violates 21 CFR 123.11(b)(1).
2. Processing equipment contact and non-contact surfaces not maintained in a sanitary condition prior to and between use to prevent food from becoming contaminated as follows:
a. The salmon dressing line was not washed and sanitized prior to the start of production on July 24, 2008. Particles of fish and fish residue could be seen on food contact and noncontact areas of the processing line both before and after the final dip tank rinse prior to freezing. Sanitation records disclosed that this line had not been thoroughly cleaned since July 17, 2008.
b. Totes used to hold ice, which was used on both processed and unprocessed fish, were not washed or sanitized prior to use. Fish waste and debris was observed in the totes as they were being filled.
This violates 21 CFR 123.11.(b)(2).
3. Failure to prevent cross-contamination from insanitary objects to food, food .packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product as follows:
a. Condensate and processing waste from an overhead transfer line for raw salmon dripping onto the food contact surface of a case-up line used for cooked crab.
b. Employees observed entering and using restrooms while wearing processing, clothing including gloves, and then seen returning to the processing area without cleaning and sanitizing their outer
c. During breaks employees were observed to store processing clothing, including gloves and other outer garments, on totes of packing materials; on containers of chemicals, such as oil and sanitizers; on the top of a restroom stall; on packaging materials, on machinery; and on tool boxes and other unsanitary areas in a machine shop area, and then return to work and handle fish without washing and sanitizing their gloves and other outer garments.
This violates 21 CFR 123.11(b)(3).
4. Food, food contact surfaces, processing equipment, and food packaging material not protected from condensate and other contaminants from ceiling-areas, overhead fixtures and equipment, and the environment as follows:
a. Condensate from ceiling areas in the salmon processing area was dripping onto freezer racks used for headed and gutted salmon;
b. Condensate from ceilings in processing areas was dripping onto cooked crab in cooking baskets.
c. Condensate was observed dripping onto a florescent light fixture, which had not been cleaned to remove processing waste, which then dripped onto freezer pans below the light.
d. Packaging material, such as a case of fish boxes, paper bagging, and plastic salmon roe boxes, was stored unprotected and exposed to environmental contaminants in the box loft.
This violates 21 CFR 123.11(b)(5)
You must conduct all food processing under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, to ensure that time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food, to comply with 21 CFR 110.80(b)(2). However, you did not conduct processing of your headed and gutted salmon in a manner that minimized the potential growth of microorganisms that contribute to decomposition, as evidenced by the exposure of salmon at room temperatures for approximately six hours on the end of a processing line before they were brought to your firm's attention by our investigator and removed for disposal.
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: ADEC, with disclosure statement