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  5. Smoked Salmon Unlimited d.b.a. H. Forman & Son - 607398 - 05/12/2020
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WARNING LETTER

Smoked Salmon Unlimited d.b.a. H. Forman & Son MARCS-CMS 607398 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Lance P. Anisfeld
Recipient Title
CEO/Owner
Smoked Salmon Unlimited d.b.a. H. Forman & Son

Fish Island, Stour Road
London
E3 2NT
United Kingdom

Issuing Office:

United States

May 12, 2020

WARNING LETTER


Reference # 607398

Dear Mr. Lance P. Anisfeld:

The United States Food and Drug Administration (FDA) inspected your seafood processing facility, located at Fish Island, Stour Road London, E3 2NT, United Kingdom on February 13 – 14, 2020. During that inspection, 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). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response sent via email on March 19, 2020. However, our evaluation of your response revealed it was not adequate because it did not include a revised HACCP plan, monitoring records, or an explanation of your corrective actions.

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 ready-to-eat (RTE) cold smoked salmon products 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.

Your significant deviations 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 plan for cold smoked salmon entitled “(b)(4),” dated September 22, 2011, does not list the food safety hazard of pathogen growth and toxin formation at the “(b)(4)” critical control point (CCP). Because cold smoked salmon products are considered a raw, ready-to-eat (RTE) food, FDA recommends that you ensure that your product is maintained below 40°F (4.4°C) throughout transit.

2. 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 implement the monitoring procedures at the “(b)(4)” and “(b)(4)” critical control point (CCP) to control Clostridium botulinum growth and toxin formation listed in your HACCP plan, entitled “Cold Smoking (USA),” for cold smoked salmon. Specifically, at the “(b)(4)” CCP, your firm is not monitoring the “(b)(4),” “(b)(4),” and “(b)(4)” to ensure your critical limits for (b)(4) and (b)(4) time are achieved.

When (b)(4) and (b)(4) critical limits are used to control C. botulinum, FDA recommends water phase salt (i.e., % salt aqueous phase) of the finished product be a minimum of 3.5% to verify that the critical limits have been achieved. On at least five separate occasions between September 26th and November 28th, 2019, your finished product testing results indicated the water phase salt levels of your cold smoked salmon products were below (b)(4)% (between (b)(4)% and (b)(4)%). No corrective actions were taken in response to these results. FDA recommends that your firm ensures that no affected product entered commerce, the cause of the deviation was corrected, and reassess the HACCP Plan.

At the “(b)(4)” CCP, your firm is not conducting a “(b)(4)” to ensure your critical limit of “(b)(4)” is achieved. FDA recommends that a visual check of the recorded temperature is performed at least once per batch.

3. 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 control records for the monitoring the condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic compounds; and control of employee health conditions.

4. 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 your cold smoked salmon products are not appropriate at the following critical control points:

a. At the “(b)(4)” CCP the corrective action of “(b)(4)” is not adequate to control pathogen growth and toxin formation. FDA recommends that affected products are chilled and held until a food safety evaluation of the cumulative ambient cooler temperature and time exposures are conducted.
b. At the “(b)(4)” CCP the corrective action is not adequate to control C. botulinum because it does not ensure that the cause of the deviation has been corrected. FDA recommends that your corrective action include making repair or adjustments to the smoker.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, process flow diagrams, hazard analysis, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

If you do not respond or if we find your response inadequate, we may take further action. 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 (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.

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 and all applicable regulations, including the seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Additionally, 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 re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). 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.

You should direct your written reply to Alyssa Piontkowski, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-607), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Piontkowski via email at Alyssa.Clendenin@fda.hhs.gov. Please reference # 607398 on any submissions and on the subject line of any emails to us.

Sincerely,
/S/

William A. Correll
Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition

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