Inspections, Compliance, Enforcement, and Criminal Investigations
Red River Seafood & Deli 12-Oct-06
Department of Health and Human Services
Public Health Service
San Francisco District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: FEI 3004747034
October 12, 2006
Carl W. Miller, Owner
Red River Seafood & Deli
2738 Westmoreland Avenue
Redwood City, CA 94063
Dear Mr. Miller:
We inspected your seafood processing facility, located at 205 Yale Avenue, Princeton By The Sea, California, on June 7, 13, and 30, 2006. 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 refrigerated, vacuum packaged, ready-to-eat cold-smoked salmon is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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:
I ) You must conduct or have conducted for,you a hazard analysis for 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 Part 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"Salmon, Vacuum Packed Cold Smoked" does not list the food safety hazard of parasites, a significant hazard associated with wild caught salmon. Please note that the parasite hazard is not controlled in cold smoked process at the smoking/cooking step as you have listed in your hazard analysis worksheet. We recommend that you see the Hazard Guide, Chapter 5 for guidance.
2) 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 critical control points, to comply with 21 CFR 123.6 (a) and (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, your firm's HACCP plan for "Salmon, Vacuum Packed Cold Smoked" does not list the critical control point of Receiving for controlling the food safety hazard of pathogen growth and toxin formation as a result of time/temperature abuse during transportation of the fish.
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 hazard." However, your firm's HACCP plan for "Salmon, Vacuum Packed Cold Smoked" lists a critical limit "Minimum internal temperature of fish at 80°F for [redacted] hours" at Smoking/Cooking critical control point that is not adequate to control pathogen growth and toxin formation, specifically Clostridium botulinum toxin formation. Your HACCP plan should include a maximum internal temperature of the fish to ensure that the product does not receive so much heat that may significantly reduce the number of spoilage organisms. Spoilage organisms must be present to inhibit the growth and toxin formation of C. botulinum type E and nonproteolytic types B and F. Although monitoring the internal temperature of the fish during smoking is an acceptable control, FDA recommends that the smoker temperature should be monitored instead.
4) You must implement the monitoring procedures and frequencies 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 procedures of "Thermocouple probes in the three thickest fish in the coldest part of oven" at Smoking/Cooking critical control point to control "bacterial pathogen survival" listed in your HACCP plan for "Salmon, Vacuum Packed Cold Smoked." For example, your Thermocouple Recording Charts for "Salmon, Vacuum Packed Cold Smoked" dated April 13/14, 2006 and May 18/19, 2006 show that only [redacted] fish for each production date was monitored at the smoking critical control point.
5) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the Brining and Cooler Storage critical control points to control pathogens and C botulinum toxin formation listed in your HACCP plan for "Salmon, Vacuum Packed Cold Smoked."
6) You must maintain sanitation control records that; at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11 (c). However, your firm did not maintain sanitation monitoring records for
a) Safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;
b) Condition and cleanliness of food contact surfaces;
c) 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;
d) Maintenance of hand washing, hand sanitizing, and toilet facilities;
e) Protection of food, food packaging material, and food contact surfaces from adulteration;
f) Proper labeling, storage, and use of toxic compounds;
g) Control of employee health conditions; and
h) Exclusion of pests from the food plant.
These records are required for the processing of vacuum packed, ready-to-eat cold smoked salmon.
7) 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 plan for "Salmon, Vacuum Packed Cold Smoked" at the Smoking/Cooking critical control point to control pathogens is not appropriate. Your corrective action does not correct the cause of the deviation, e.g., make repair or adjustments to the smoking chamber at the Smoking/Cooking critical control point.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This, form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and' Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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 in violation of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)) and the seafood HACCP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H.
You should respond in writing within fifteen (15) working days of 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), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Ms. Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay
Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Ms. Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District