Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700
VIA UNITED PARCEL SERVICE
Our Reference: CMS 433731
November 14, 2014
Stephen T. Rose, President
Hickory Smokehouse of Las Vegas, Inc.
4396 E. Alexander Road
Las Vegas, Nevada 89115
Dear Mr. Rose:
We inspected your seafood processing facility, located at 4396 E. Alexander Road, Las Vegas, Nevada on May 8, 9, 21, 22, and 23, 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 and frozen, vacuum packaged, ready-to-eat hot and cold smoked fish and fishery products including salmon and trout are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Additionally, our review of the labeling for your Fjord Dawn Smoked Salmon, Highland Reserve Smoked Salmon, Imperial Salmon House Smoked Atlantic Salmon, and MacKnight Traditional Hot Smoked Idaho Trout revealed that these products are misbranded within the Section 403 of the Act and the regulations contained within 21 Code of Federal Regulations Part 101 (21 CFR 101). You may find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance and all other regulations through links in FDA's home page at www.fda.gov.
Your serious deviations are as follows:
(1) 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,
(a) your firm’s HACCP plan for refrigerated, vacuum-packaged, ready-to-eat “Cold Smoked Salmon” lists a critical limit (b)(4) at the Smoking critical control point (CCP) that is not adequate to control pathogen growth and toxin formation during the smoking process. On May 9 and 21, 2014, our investigator observed racks of salmon fillets, previously rubbed with (b)(4), were kept in the Curing Room (your Smoking CCP) for 8 hours. On May 9, 2014, the Curing Room temperature ranged from 72-77°F; on May 21, 2014, the temperature ranged from 55-75°F. The investigator did not observe actual smoke or liquid smoke applied to the salmon fillets at this curing or smoking process and your description of your process does not include these steps. The application of smoke during the cold smoking process inhibits pathogen growth and toxin formation that would normally occur at cold smoking temperatures. You are not using actual smoke which inhibits all pathogens during the smoking process. Since you are using a (b)(4) process at the Smoking CCP, your firm needs to provide scientific support that the application of the (b)(4) provides an equivalent inhibitory effect to the application of actual smoke or liquid smoke to control pathogen growth and toxin formation. If you cannot obtain and provide scientific support that your (b)(4) process is equivalent to the application of actual smoke or liquid smoke, then your critical limit (b)(4) at the Dry Salting CCP is also not adequate to control Clostridium botulinum toxin formation in your vacuum-packaged finished product. The critical limit would need to be 5% or more water phase salt since the combination of the interaction of salt, temperature, and smoke allow for the lower phase salt of 3.5%
On July 18, 2013, the FDA Florida District Office sent a letter concerning the same issue as above. Florida district also requested that you provide scientific support that the dry smoke product provides an inhibitory effect equivalent to the application of actual smoke or liquid smoke to control pathogen growth and toxin formation including Clostridium botulinum toxin in the finished product.
On May 23, 2014, at the closeout meeting with the management staff at your Las Vegas facility, our investigator discussed her FDA 483 observation that is related to the (b)(4) process. She asked Mr. Christopher J. Rayson, Vice-President, if your firm has a scientific study to show that your (b)(4) smoking process is equivalent to the application of actual smoke or liquid smoke. Mr. Rayson provided our investigator a copy of a lab test result, dated 05/14/2014, from (b)(4), showing that the ash content of a composite of Batches (b)(4) (type of product not specified) was 2.90%. This lab report does not address our concerns at all. Additional information demonstrating the inhibition of pathogen growth during the curing process and the inhibition of Clostridium botulinum in the finished product should be provided to support the safety of your current process.
(b) your firm’s HACCP plan for vacuum packaged, ready-to-eat “Cold Smoked Salmon” also lists a critical limit (b)(4) at the Vacuum Packaging/Labeling CCP that is not adequate to control Clostridium botulinum toxin formation. FDA recommends including with your critical limit a statement that each product package bears the “Keep Frozen…” label warning.
(c) your firm’s HACCP plan for vacuum packaged, ready-to-eat “Hot Smoked Trout” lists a critical limit, (b)(4) that is not adequate to control Clostridium botulinum in the finished product. Your product label for Hot Smoked Trout states “Keep refrigerated under 38F. If Frozen Thaw under refrigeration before use. Keep frozen” at the Vacuum Packaging/Labeling CCP. FDA’s position is to take into consideration the higher risk product. In this case, your HACCP plan does not include adequate controls for Clostridium botulinum for your refrigerated hot smoked trout. FDA recommends parameters to achieve a critical limit of equal or greater than 3.5% WPS.
(2) Because you chose to include a corrective action in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for “Cold Smoked Salmon” lists, (b)(4) at the Storage of Fresh Salmon, Thawing, Dry Salting CCP, and Finished Product Refrigerated Storage CCPs, to control pathogen growth, including Clostridium botulinum toxin, is not appropriate. Further, your corrective action plan does not include final disposition of the affected product to ensure that unsafe product does not enter commerce. When a critical limit is exceeded, FDA recommends chilling and holding the product until an evaluation of the total time and temperature exposure is performed, including exposures during prior processing operations. Please note that some pathogens can grow in less than 3 hours when exposed to temperatures above 70°F.
Note that the above-mentioned HACCP deviations would carry over to all your cold smoked and hot smoked fishery products that are processed in the same manner.
We have reviewed the labels for your Fjord Dawn Smoked Salmon, Highland Reserve Smoked Salmon, Imperial Salmon House Smoked Atlantic Salmon, and MacKnight Traditional Hot Smoked Trout fishery products and determined that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Specifically,
(1) Your Fjord Dawn Smoked Salmon, Highland Reserve Smoked Salmon, and Imperial Salmon House Smoked Atlantic Salmon are misbranded within the meaning of section 403(a)(l) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading in any particular. Specifically, the product labels indicate that the products are smoked or smoke-flavored fishery products, which are defined in 21 CFR 123.3(s); however, they do not meet the definition. Our investigator did not observe the product being subjected to the direct action of smoke and/or imparting to it the flavor of smoke by a means such as immersing the product in a solution of wood smoke. Further, your representative told our inspector that your facilities use (b)(4) on your ready-to-eat, vacuum packed, cold smoked salmon in place of smoke from burning wood, sawdust or similar material and/or a solution of wood smoke. Specifically, the product labels indicate that the products are smoked or smoke-flavored fishery products as follows:
a. the bulk containers for Fjord Smoked Salmon and Highland Reserve Smoked Salmon declare an ingredient “natural hickory smoke.”
b. the Fjord Smoked Salmon's individual product packaging states “[W]e dry cure the salmon with a blend of salt and sugar before cold smoking over smoldering oak wood chips.”
c. the individual product packaging for Imperial Salmon House Smoked Atlantic Salmon Smoked Atlantic Salmon and Highland Reserve Smoked Salmon state “[W]e dry cure the salmon with a natural blend of salt & brown sugar cold smoking each fillet.”
d. the individual product packaging for Imperial Salmon House Smoked Atlantic Salmon bears the statement “Freshly Smoked 'Au Naturale.’”
(2) Your Fjord Dawn Smoked Salmon, Highland Reserve Smoked Salmon and MacKnight Traditional Hot Smoked Trout products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C.§ 343(i)(2)] because they are fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient as required by 21 CFR 101.4(a). Specifically,
a. the outer container of the Fjord Dawn Smoked Salmon and Highland Reserve Smoked Salmon shipping carton states, “Ingredients: Global-gap farmed atlantic salmon, sodium nitrite, erythordate, sea salt, brown sugar, natural hickory smoke.” Global-gap farmed salmon is not the common or usual name for salmon. We also note that the ingredient used in the manufacture of these products was observed to be “sodium erythorbate” rather than “erythordate” as declared on the label.
b. the individual plastic packaging for the Fjord Dawn Smoked Salmon fails to declare an ingredient statement. We note that you told our investigator during the inspection that you consider your products as bulk pack and they will not be sold at retail by your customers; therefore, you only affix a sticker on the bag when the customer requires it. However, the individual plastic packaging for your products is not considered bulk packaging and must declare an ingredient statement; thus, the products that do not include an ingredient statement sticker are misbranded under 403(i)(2).
c. the MacKnight Traditional Hot Smoked Trout sticker labels used on your outer package (40 lb) and individual package (1.07 lb) states “Ingredients: Idaho Trout, sea salt, brown sugar, natural hickory smoke.”
i. The declaration of “natural hickory smoke” fails to declare “flavorings” in accordance with 21 CFR 101.22;
ii. “Idaho Trout” is not an acceptable market name listing for a fish according to The Seafood List;
iii. Your product contains sodium nitrite; however, the ingredient statement fails to list this ingredient. FDA collected and analyzed a sample of your hot smoked trout, represented by Sample 834782, during the inspection and found nitrite levels at 27 ± 7 µg NaNO2.
(3) Your Fjord Dawn Smoked Salmon, Imperial Salmon House Smoked Atlantic Salmon, and Highland Reserve Smoked Salmon are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)]. The bulk container for Fjord Dawn Smoked Salmon and the individual product packaging for Imperial Salmon House Smoked Atlantic Salmon and Highland Reserve Smoked Salmon fail to declare the name and place of business of the manufacturer, packer, or distributor, as required under 21 CFR 101.5. The declaration of the name and place of business of the manufacturer, packer, or distributor is required on both bulk and retail packaging. We note that under 101.5(d), the statement of the place of business must include the street address unless it is shown in a current city directory or telephone directory.
(4) Your MacKnight Traditional Hot Smoked Trout is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears a chemical preservative, namely sodium nitrite, and your bulk container fails to declare its presence as required by 21 CFR 101.22(b). During the current inspection, FDA collected and analyzed a sample of your hot smoked trout, represented by Sample 834782, and found nitrite levels at 27 ± 7 µg/g NaNO2. In addition, your Fjord Dawn Smoked Salmon and Highland Reserve Smoked Salmon products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the products bear or contain a chemical preservative, sodium nitrite; however, the labels do not include a separate description of the function of this chemical preservative, as required by 21 CFR 101.22(j). In accordance with 21 CFR 101.22(j), a food to which a chemical preservative is added shall, except when exempt pursuant to 21 CFR 101.100, bear a label declaration stating both the common or usual name of the ingredient and a separate description of its function, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention,” as required by 21 CFR 101.22(j).
(5) Your Imperial Salmon House Smoked Atlantic Salmon product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. The product package has an additional nutrition label in another country’s format. This format is not allowed under 21 CFR 101.9.
The issues and violations described above are not meant to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act, the seafood HACCP regulation (21 CFR 123), and all applicable FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and injunction under sections 302 and 304 of the Act [21 U.S.C. §§ 332 and 334].
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations cited in this letter. Your response should outline the specific things you are doing to prevent the recurrence of violations. 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 corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
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 433731 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 Office