Inspections, Compliance, Enforcement, and Criminal Investigations
Roundman's Smokehouse 5/30/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
VIA UNITED PARCEL SERVICE
Our Reference: CMS 429570
May 30, 2014
Stephen J. Rasmussen, Co-owner
412 North Main Street
Fort Bragg, California 95437
Dear Mr. Rasmussen:
We inspected your seafood processing facility, Roundman’s Smokehouse, located at 412 North Main Street, Fort Bragg, California, on February 25 and 27, 2014. 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 vacuum packaged ready-to-eat smoked albacore tuna and sockeye salmon 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.
At the close of the inspection, the investigators provided you with the form FDA 483 which presents their evaluation of your firm’s performance regarding various aspects of the HACCP requirements. We attached a copy of the FDA 483 for your reference.
Your significant violations, which were based on the inspection and further review of your HACCP plans, are as follows:
1. 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 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 plans “SMOKED SALMON” and “SMOKED ALBACORE” do not list the food safety hazard of allergens. FDA has identified allergens as a food safety hazard and must be included in your HACCP plans.
We acknowledge receipt of your e-mail dated March 22, 2014. To address the above deviation, you stated that both your HACCP plans for Smoked Salmon and Smoked Albacore will address the allergens for finfish. We will verify your corrective action during the next inspection of your facility.
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 plans for “SMOKED SALMON” and “SMOKED ALBACORE” list critical limits (b)(4) at the Brining (b)(4) critical control point that are not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. FDA recommends including a critical limit related to the thickness of your salmon and albacore, to ensure that finished product does not have less than 3.5% water phase salt, or where permitted, the combination of 3% water phase salt and not less than 100 ppm nitrite. Note that nitrite used in salmon should not exceed a level of 200 ppm and 10 ppm in tuna, according to 21 CFR 172.175. In addition, FDA recommends quarterly testing of your % water phase salt to verify that your firm is achieving adequate control for pathogen growth and toxin formation, including Clostridium botulinum toxin.
To establish the appropriate monitoring procedures, corrective actions, verification procedures, and record keeping system for the critical limits related to Clostridium botulinum toxin control, please refer to Chapter 13 of the HACCP Guide, 4th Edition.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However,
(a) your firm’s HACCP plan for “SMOKED SALMON” does not list a monitoring procedure for the (b)(4), at the Brining (b)(4) critical control point, to control pathogen growth and toxin formation including Clostridium botulinum toxin.
We acknowledge your emailed response dated 3/22/14 to the above deviation, where you stated that your firm has been monitoring the (b)(4) and you will make sure that your HACCP plan reflects this action. We will verify your corrective action during the next inspection of your facility.
(b) your firm’s HACCP plans for “SMOKED SALMON” and “SMOKED ALBACORE” list a monitoring procedure, (b)(4) the Cooler Storage for raw materials (b)(4) and for finished products (b)(4) critical control points, is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin in the smoked salmon, and including histamine in the smoked albacore. Please note that FDA no longer recommends the use of high temperature alarms for monitoring temperatures in coolers or processing areas. FDA recommends continuous monitoring of the cooler temperature by the device (recording thermometer) itself, with a visual check of the recorded data at least once a day.
You stated in your response of March 22, 2014 that you are currently researching products that are cost effective and accurate for monitoring your refrigerators. Sufficient time has passed since the inspection and we expect that you have found the appropriate temperature-monitoring device and have corrected the above deviation.
(c) your firm’s monitoring procedure for the (b)(4) critical limit of your smoked salmon and smoked albacore HACCP plans do not list the appropriate instrument (b)(4) for measurement. During the inspection, the investigators observed that your brining records did not list the results of the (b)(4) measurements. On February 27, 2014, at the close-out meeting, you informed the investigators that you have no (b)(4) but indicated that you will purchase one and revise your HACCP plans.
You stated in your response of March 22, 2014 that you will start monitoring and document the (b)(4) as a critical limit. We will verify your corrective action during the next inspection of your facility.
Please refer to Chapter 7 and Chapter 13 of the HACCP Guide, 4th Edition for additional information related to adequate monitoring procedures in controlling histamine and pathogen growth and toxin formation including Clostridium botulinum toxin.
4. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogen growth and toxin formation including Clostridium botulinum toxin when your process for smoked salmon deviated from your critical limit (b)(4) at the Smoking (b)(4) critical control point. Your HACCP record (b)(4) shows that on 2/14/14, a batch of salmon was smoked for only 25 minutes; fish internal temperature of 145°F was reached at 10:45 am and out of the smoker at 11:10 am.
5. 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,
(a) your corrective action plan for ”SMOKED SALMON” and “SMOKED ALBACORE” at the Brining (b)(4), Smoking (b)(4), and Chilling (b)(4) critical control points does not have provisions to ensure that the cause of the process deviation is corrected.
(b) your corrective action plan (b)(4) for “SMOKED SALMON” and “SMOKED ALBACORE” at the Cooler Storage (b)(4) critical control point for raw material and Cooler Storage (b)(4) critical control point for finished products, does not ensure that that all affected products do not enter commerce. Your corrective action plan does not explain how you will determine which lot is adulterated among your seafood products.
We acknowledge your March 22, 2014 response to the above deviations. Please note that in evaluating the total time and temperature exposure of all the various lots of product held in your cooler at the time of the deviation, you must also include exposures during prior processing operations.
6. You must monitor sanitation conditions and practices with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11. However, your firm did not monitor the following areas of sanitation as evidenced by your (b)(4) record for processing days 2/24/14 and 2/25/14:
(a) Prevention of cross-contamination from insanitary objects to food;
(b) Maintenance of toilet facilities; and
(c) Protection of food, food packaging material, and food contact surfaces from adulterants.
We acknowledge your emailed response dated 3/22/14 to the above observations associated with sanitation. We will verify your corrective action during the next inspection of your facility.
We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from operating.
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 copies of the revised HACCP plans, 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 and the seafood HACCP regulation (21 CFR Part 123). 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: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. Please reference the CMS number 429570 in your response.
If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
Kathleen M. Lewis, J.D.
San Francisco District