Inspections, Compliance, Enforcement, and Criminal Investigations
Orval Kent Food Company, Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
September 23, 2009
Jorge H. Villalobos
Orval Kent Food Company, Inc.
d/b/a/ Fish House Foods, Inc.
3285 Corporate View
Vista, CA 92081-8528
Dear Mr. Villalobos:
We inspected your seafood processing facility, located at 3285 Corporate View, Vista, California
on May 12-13, 2009, and subsequently received your response letter to FDA dated June 9, 2009
regarding the FDA-483 items disclosed during the May inspection. 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 (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 ready-to-eat fishery products such as salmon, vacuum-packaged clam chowder and similar 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: 3rd Edition (the Hazard Guide) 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 the critical control points, to comply with 21 CFR 123.6(c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plans for "Steamed Salmon" and "Seafood Cooked - Clam Chowder" [revised and dated 06/02/09] do not list the critical control point of refrigerated storage for controlling the food safety hazard of pathogen growth and toxin production in the finished products. Your response dated June 9, 2009, which indicates that your firm intends to address refrigerated storage as a prerequisite program, is inadequate because a prerequisite program is not a substitute for a critical control point necessary to reduce or eliminate a hazard that is reasonably likely to occur. Your revised plans identify pathogens as reasonably likely hazards, and as such, in the absence of controls these hazards are reasonably likely to result in adulteration of the finished foods. Consequently, your HACCP plans need to include the necessary critical control points, such as refrigerated to reduce or eliminate the likelihood for the hazard.
2. You must conduct or have conducted for you a hazard analysis fore 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 "Seafood Cooked - Clam Chowder" (revised and dated 06/02/09) does not list the food safety hazard of Clostridium botulinum growth and toxin formation. Clostridium botulinum toxin formation is reasonably likely as a hazard in products packed in reduced oxygen packaging materials and/or materials that are oxygen impermeable. Your soup products are packaged in a bag that has an oxygen permeability rate of: (b)(4), which is below the rate recommended by the Agency for control of the hazard. With regard to your response concerning the reduced likelihood for Type E based on your firm's use of canned clams Type E, Clostridium botulinum remains relevant to your claim chowder product due to the presence of other fish within your facility. In addition, there remains the concern for the non-proteolytic types of Clostridium botulinum forms B & F that may be present in the raw materials used in the production of the clam chowder, such as the dehydrated potatoes, onions and peppers
For additional information related to the hazard of Clostridium botulinum, please refer to Chapter 13 of tile Fish and Fisheries Hazards and Controls Guidance: 3rd Edition (the Hazard Guide). Strategies suggested in Chapter 13 for control of Clostridium botulinum include adequate cooking (i.e., adequate cook critical limit values for time and temperature combinations) to inactivate the nonproteolytic strains of Clostridium botulinum. Table #A-4 in the Hazard Guide provides various time and temperature combinations adequate to achieve a 6D process (in minutes) for inactivation of the nonproteolytic Clostridium botulinum type B. In lieu of a cook/thermal process, you may choose to use product formulation to inhibit growth such as with pH or water activity controls; or you may choose to use time-temperature integrators on each finished package of clam chowder that would alert customers to time/temperature abuse.
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
If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 608-4409. Your written reply should be addressed to:
James P. Stumpff
Acting Director, Compliance Branch
U. S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612
Alonza E. Cruse, Director
Los Angeles District
cc: Mark L. Brown, President
Orval Kent Food Company, Inc.
120 Wesy Palatine Road
Wheeling, IL 60090
cc: Jeff Farrar, DVM, PhD, MPH
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue-MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413