Inspections, Compliance, Enforcement, and Criminal Investigations
Fog River, LLC 3/2/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
March 2, 2011
Mr. John B. Bowen
Fog River, LLC
1360 South Redwood Road
Salt Lake City, UT 84104
Dear Mr. Bowen:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 1360 South Redwood Road, Salt Lake City, Utah, on December 19-22, 2011. 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 offish 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 frozen and fresh seafood products 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 conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you process to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for canned crabmeat, vacuum packaged smoked salmon and raw amberjack (Kampachi) to control the food safety hazard of pathogen growth.
We acknowledge receipt of your letter dated January 10, 2012 responding to our form FDA 483, Inspectional Observations issued to you on December 22, 2011. Your response to this deviation is inadequate because although you provided copies of your new HACCP plans for canned crabmeat and vacuum packaged smoked salmon, you did not provide a HACCP plan for raw amberjack fish (Kampachi).
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 scombroid finfish lists a critical limit, of"product must be received with adequate cooling media" at the receiving critical control point that is not adequate to control the possible hazard of histamine.
Your response appears to address this deviation.
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 "Continuous, with visual check of recorded data twice per day" at the refrigerated storage critical control point to control histamine formation listed in your HACCP plan for scombroid finfish.
Your response to this deviation is inadequate because you did not provide any documentation of use or monitoring of the "TTR" device you reported installing.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products 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 reply to: Food and Drug Administration, P.O. Box 25087, (6th Avenue and Kipling Street, DFC, Bldg 20), Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Mr. Sherer at (303) 236-3051, or by email at firstname.lastname@example.org
LaTonya M. Mitchell
Denver District Director