Inspections, Compliance, Enforcement, and Criminal Investigations
Riverside Food Manufacturing Corporation 14-Jul-03
Public Health Service
|19900 MacArthur Blvd., Ste 300
Irvine, California 92612-2445
Telephone (949) 798-7600
RETURN RECEIPT REQUESTED
July 14, 2003
Mr. Edgar W. Mosley
Riverside Food Manufacturing Corporation
166 19 South Broadway
Carson, CA 90248
Dear Mr. Mosley:
On March 12- 17, 2003, we inspected your seafood processing facility, located in Carson, California. Based on our inspection and the HACCP plans which were not given to us until after the inspection, we found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulation, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products adulterated within the meaning of Section 402(a)(4) ofthe Federal Food, Drug, and Cosmetic Act (the Act), 2 1 U.S.C 342(a)(4). Accordingly your vacuum-packaged, refrigerated dried, cooked/smoked and marinated fishery products are adulterated, in that these products 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 and Controls Guidance, Third Edition, June 2001, through links in FDAs home page at www.fda.gov
Your-deviations are as follows:
1. You must conduct a hazard analysis 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 Part 123.3 (f) as any biological, chemical, or physical property that may cause a food to be unsafe for human consumption. However:
a. Your firms HACCP plan for Cooked, Smoke Flavored Fish does not list the food safety hazard of undeclared FD&C Yellow # 5, etc. at the labeling CCP.
b. Your firms HACCP plan for Dried Fish does not list the food safety hazard of histamine formation, pathogen growth and toxin formation at the Drying CCP. Since the product is dried [redacted] there is a potential for pathogen growth and toxin formation.
2. You must conduct, or have conducted for you, a hazard analysis to determine the food safety hazards that are reasonably likely to occur and to identify the preventive measures necessary to control those hazards, and you must have a HACCP plan that lists the critical control points to comply with 21 CFR 123.6(a) and 123,6(c)(2). A critical control point is defined in 21 CFR Part 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, critical control points were lacking or deficient for your HACCP
plans as outlined below:
a. Your HACCP plan for vacuum packaged Cooked, Smoke Flavored Fish relies exclusively on refrigeration as a control for Clostridium botulinum. To control the nonproteolytic strains of C. botulinum, FDA recommends that vacuum packaged refrigerated products have a double barrier, e.g. in the form of salt, water activity, heat inactivation or pH in combination with refrigeration at 40°F.
If you choose heat inactivation applied to the finished product as a means of controlling the nonproteolytic strains C. botulinum you should consult Table #A-4 of the The Fish and Fisheries Products Hazards and Controls Guidance. Third Edition, June 2001 to ascertain adeouate parameters for accomplishing this.
If you choose to use refrigeration at 38°F as the sole barrier to the outgrowth of this organism, then a Time Temperature Integrator or Indicator (TTI) should be used as a continuous monitor of temperature. A TTI indicates by a color or other visual change if the product has been exposed to a time and temperature combination that could result in an unsafe product, FDA recommends that TTIs, with clear instructions for their interpretation, be placed on each package.
b. Your HACCP plans for Marinated Milkfish and Dried Fish do not have finished product storage listed as a CCP for controlling the food safety hazard of C. botulinum growth and toxin formation.
3. 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 Part 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 Marinated Milkfish lists a critical limit of [redacted] that is not adequate to control the hazard of C. botulinum growth and toxin formation. If you choose to control this hazard by lowering the pH, as you have done, you should specify and monitor the parameters in the Marinating Step that will consistently result in a pH of 4.6 or below in the finished product. You can establish those parameters in a carefully designed study in which the parameters are varied and the finished fish product pH is measured. A pH of 4.6 in the brine will not result in a pH of 4.6 in the finished fish product.
4. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, for your firms "Dried Fish" HACCP plan, your firm did not verify the adequacy of critical limits of [redacted] and [redacted] at the "Brining" CCP or [redacted] at the "Drying" CCP to control the hazard of C. botulinum growth and toxin formation. Instead of testing your product to determine if the water phase salt is 10%, or the pH is 4.6 or less, your firm indicated that Mr. Hernandez touches the product to determine if it dry enough. Once you have established the critical limits that consistently result in a water phase salt of 10% or a pH of 4.6 or less, you should establish and implement adequate monitoring procedures and frequencies.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to recommend that the U. S. Government seize your product(s) and/or enjoin your firm from operating.
We acknowledge your letter dated April 2, 2003 in which you responded to the inspectional observations made during the above noted inspection, We also acknowledge the HACCP plans that were provided. These HACCP plans are deficient in a number of respects as noted above.
Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should include each step that has been taken to completely correct the current violations and to prevent the recurrence of similar violations, the time within which correction will be completed, and any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP Regulation 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Your written reply should b e directed to:
Director, Compliance Branch
U.S. Food & Drug Administration
19900 MacArthur Blvd, Suite 300
Irvine, CA 92612-2445.
If you have questions regarding any issue in this letter, please contact Mr. Robert B. McNab, Compliance Officer at (949) 798-7709.
Alonza E. Cruse