Inspections, Compliance, Enforcement, and Criminal Investigations
The Santa Barbara Smokehouse, Inc. 9/12/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
September 12, 2012
Timothy R. Brown, CEO / Owner
The Santa Barbara Smokehouse, Inc.
312 N Nopal St.
Santa Barbara, CA 93103-3225
Dear Mr. Brown:
We inspected your seafood processing facility, located at 312 N Nopal St., Santa Barbara, California on April 30 and May 1 through 4, 2012.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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).
Accordingly, your ready-to-eat vacuum packed smoked salmon products are adulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby theymay 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.
We acknowledge receipt of your written response dated May 17, 2012. We have reviewed your response, which included an updated HACCP plan, as well as corresponding records. However, based on your response and your HACCP plan that was provided, your ready-to-eat, vacuum packed smoked salmon products continue to be adulterated. We address your response below, in relation to each of the noted violations. The significant violations are as follows:
- 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 plan for “Smoked Salmon” does not list the food safety hazards of parasites or undeclared allergens in the finished product.
The hazard analysis provided with your response identifies a Critical Control Point (CCP) for both parasites and food allergens and your response states you have added these CCPs to your HACCP plan. However, the revised plan dated May 11, 2012 which was provided with your response does not identify the hazard of parasites or undeclared allergens or include the corresponding CCPs.
- 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 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 “Smoked Salmon” does not list the critical control point of “Thawing” (i.e. under refrigeration) for your cold smoked salmon (b)(4), to control the food safety hazard of Clostridium botulinum growth and toxin formation.
Your response stated that you will create a HACCP plan for (b)(4) prior to resuming (b)(4) and submit a copy for review. However, to date a revised HACCP plan has not been received.
- 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 revised HACCP plan for “Smoked Salmon” provided with your response lists a critical limit of “Product Core temperature (b)(4), at the (b)(4) (CCP4A) critical control point that is not adequate to control the hazard of “Growth of pathogenic organisms and toxins (Clostridium botulinum, Listeria sp.)”. This critical limit is inadequate to control the hazard of Clostridium botulinum growth and toxin formation. If you intend for this product to be hot smoked you should follow the guidance in Chapter 13 of the Fish and Fishery Products Hazards and Controls Guidance (FFPHG) Fourth Edition for the appropriate control strategy (i.e. hot smoking at or above 145ºF /62.8ºC throughout the fish (internal temperature) for at least 30 minutes). If you do not intend for this product to be hot smoked you should follow the guidance in the FFPHG for cold smoking (i.e. temperature not to exceed 90ºF/32.2ºC).
- Your firm’s revised HACCP plan for “Smoked Salmon” provided with your response lists a critical limit of “Internal core temperature of fish on arrival to factory (Fresh (b)(4)) (Frozen (b)(4))” at the “Fish Receiving” (CCP 1) critical control point that is not adequate to control the hazard of “Growth of pathogenic organisms and toxins (Clostridium botulinum, Listeria sp.)”. Your response states that you added the monitoring of “gel ice (b)(4)”, however this is not an adequate control strategy for the products you receive that have a transit time equal to or greater than 4 hours. A more appropriate control strategy is to monitor the internal product or ambient air temperature during transit using a continuous temperature-recording device; or for products held under chemical cooling media, such as gel packs, make visual observations of the adequacy and frozen state of the cooling media in a representative number of containers from throughout the shipment at delivery AND determine internal product temperatures in a representative number of product containers from throughout the shipment at delivery. Please refer to Chapter 12 of the FFPHG for guidance on an appropriate control strategy.
- 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 of “Water phase salt (b)(4) at the “Salting/Curing” (CCP3) critical control point for your vacuum packed cold smoked “Sushi Style Smoked Salmon” listed in your “Smoked Salmon” HACCP plan to control the food safety hazard of Clostridium botulinum growth and toxin formation.
Your response is inadequate because it is incomplete. You stated that you are investigating modifying the product to achieve a (b)(4) WPS but (b)(4).
We acknowledge your labeling correction to add the statement “Important Keep Frozen Open Package and Thaw Under Refrigeration Immediately Before Use” to your (b)(4) Brand cold smoked salmon that you distribute frozen. However, if you choose to use freezing to control the hazard of Clostridium botulinum growth and toxin formation for your vacuum packed products they should include appropriate labeling to ensure that the product is held frozen throughout distribution and thawed under refrigeration. In addition, controls should be in place to ensure that such products are immediately frozen after processing, maintained frozen throughout storage in your facility, and labeled to be held frozen and to be thawed under refrigeration immediately before use. Please refer to Chapter 13 of the Fish and Fishery Products Hazards and Controls Guidance (FFPHG) Fourth Edition for the appropriate control strategy.
- 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 listed in your “Smoked Salmon” HACCP plan dated May 11, 2012 provided with your response, at the “Fish Receiving” (CCP1), critical control point to control the hazard of “Growth of pathogenic organisms and toxins (Clostridium botulinum, Listeria sp.)” is not appropriate. Your corrective action plan does not address the cause of the deviation (i.e. discontinue supplier until evidence is obtained that transportation handling practices have been improved).
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of the water that comes into contact with food or food contact surfaces, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, and protection of food from adulteration with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
- Hoses used for cleaning equipment and other food contact surfaces throughout the facility and used to dispense chlorine dioxide lack backflow prevention devices.
- Chlorine based sanitizer used for spraying food contact surfaces was measured to be at over 400 PPM by the FDA Investigator. The container was labeled as 200 PPM.
- A table in the de-boxing area of the “low-care” room was observed to have pieces of raw salmon after it had been identified as clean and sanitized.
- The process for washing loins (b)(4). Spray from the hose was observed splashing on the floor and coming into contact with raw, in-process loins (b)(4). The same process is used for washing loins after curing.
- The captive boots worn by employees in the “low-care” area were observed to have an accumulation of residue in the threads.
- An employee was observed picking up a napkin from the floor and then touching cold smoked salmon before vacuum packing prior to washing their hands.
- Approximately (b)(4) filled with racks of raw salmon loins in the “low-care” area were placed under a cooler unit in the de-boxing area which was observed to be dripping onto the raw salmon loins. (b)(4) were placed under the cooler unit in the thawing room which had an accumulation of drip in the lower surface.
In addition, your sanitation control records do not accurately reflect the conditions or practices observed at your firm. Your sanitation monitoring records corresponding to the dates of the observations listed above indicate acceptable conditions.
We acknowledge some of the corrections you have made pertaining to this observation. However, your written response is only partially adequate in that you were not able to provide evidence of completion for some of the items listed above. For example, you promised to install back flow prevention devices on all connections inside and outside the building but did not provide evidence of completion. We also have concerns with your method of washing fillets which involves (b)(4). This process does not appear adequate to control cross contamination. In regards to the items involving employee practices, the adequacy of these corrections cannot be verified at this time and will be verified during the next inspection of your firm. In addition, your written response does not identify how you will continue to monitor employee practices and sanitation to prevent future occurrences.
- You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR § 123.12 (a)(2)(ii). However, your firm did not perform an affirmative step for “fresh” (refrigerated) (b)(4) you imported from (b)(4).
Your response did not include any documentation that shows you have met the importer requirements under 21 CFR § 123.12.
- Due to the number of critical control points listed in your plan and the fact that not all the CCPs apply to all products, we suggest you develop a separate HACCP plan for each product type with the corresponding CCPs (i.e. cold smoked, hot smoked, refrigerated, frozen, etc.)
- The frequency of “Commencement of Trading with Supplier and (b)(4) there on after” listed in your “Smoked Salmon” HACCP plan, at the “Fish Receiving” (CCP1) critical control point to control the hazard of “Presence of unapproved aquaculture drugs” for the salmon you receive from growers may not be appropriate. A more appropriate monitoring frequency is lot by lot monitoring and rejection of lots lacking a compliance letter. In addition, the compliance letter should include information specific to your supplier’s use of aquaculture drugs.
- Although you provided evidence of the installation of temperature chart recorders for the continuous monitoring of your finished product storage cooler near your dry goods storage, you did not provide evidence that you are monitoring your “Finished Product Storage” (CCP8) critical control point.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
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.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
Alonza E. Cruse
Los Angeles District
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413