Inspections, Compliance, Enforcement, and Criminal Investigations
Grant's Smokehouse Ltd. 7/8/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20742
JUL 8, 2013
VIA EXPRESS DELIVERY
Mr. Alex McMorran
Grant's Smokehouse, Ltd.
Site 14 Solway Industrial Estate
Maryport CA 15 8NF
Reference No. 398456
Dear Mr. McMorran:
We inspected your seafood processing facility, Grant's Smokehouse Ltd., located at Site 14 Solway Industrial Estate, Maryport CA 15 8NF, Cumbria, England, United Kingdom, on January 14-15, 2013. During that inspection, we found that you had 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 a form FDA-483, Inspectional Observations, listing the deviations found at your firm.
We acknowledge receipt of your initial response sent via email on February 5, 2013, that addressed the sanitation (i.e., GMP) conditions observed at your firm. We additionally acknowledge the HACCP documentation your firm sent via email on March 11, 2013. Your March 2013 response included several documents, including a HACCP Risk Assessment, a revised HACCP plan entitled “(b)(4) - CCP Summary Sheet January 2013 FDA Inspection,” and monitoring records. However, our evaluation of the HACCP-related documentation found that the response was not adequate, as further described in this letter.
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 hot and cold-smoked salmon products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through FDA's home page at www.fda.gov.
The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviation is as follows:
1. You must have and implement a written HACCP plan for each kind of fish and fishery product processed to comply with 21 CFR 123.6(b)(2). In accordance with 21 CFR 123.6(b)(2), firms may group kinds of fish and fishery products together, or group kinds of production methods together in one plan, only if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed are identical for all fish and fishery products so grouped or for all production methods so grouped. Your HACCP plan entitled “(b)(4) - CCP Summary Sheet January 2013 FDA Inspection” combines two products, cold-smoked salmon and hot-smoked salmon; however, these products do not have identical processes.
Your plan lists “CCP2 – Hot-Smokecook” that indicates a control measure, critical limit, monitoring, corrective action, documents and records that are distinctly different than the process listed for “CPP7 - Control of the (b)(4).” Additionally, the HACCP plan indicates that (b)(4). Because the control measures, critical limits, and other parameters are different, a separate plan needs to be developed for each product (one plan for cold-smoked salmon and one plan for hot-smoked salmon).
In addition to the significant deviation noted above, review of your HACCP plan entitled “(b)(4) – CCP Summary Sheet January 2013 FDA Inspection” revealed the following deficiencies:
1. In order to comply with 21 CFR 123.6(a) and (c)(2), you must develop a critical control point for each point, step, or procedure in a food process at which control can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable levels. Your firm's HACCP plan entitled “(b)(4) - CCP Summary Sheet January 2013 FDA Inspection” does not include necessary critical control points as follows:
a. Your plan associated with your hot-smoked salmon does not include a critical control point for refrigerated storage of finished product to control pathogen growth, including Clostridium botulinum growth and toxin formation.
b. Your plan associated with your cold-smoked salmon product does not include:
o a critical control point for receipt of the fish to control pathogen growth. Because cold-smoked fish will not receive a heat treatment/kill step to control pathogen growth on the incoming raw materials, firms must include a receiving critical control point to ensure that fish were held at proper temperatures during transport to your facility.
o a critical control point or points for holding the raw material and in-process salmon prior to the cold-smoke process to control pathogen growth. Our inspection revealed that your firm (b)(4). FDA recommends that your firm assess via your hazard analysis the need for additional storage critical control points (i.e., refrigeration of raw material and in-process holding) to control pathogen growth during these holding periods to prevent pathogen growth as a result of time and temperature abuse.
2. In order to comply with 21 CFR 123.6(c)(3), you must develop critical limits for each critical control point. A critical limit is defined 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, for each critical control point.” However, the critical limits listed in your firm's HACCP plan portion of the “(b)(4) - CCP Summary Sheet January 2013 FDA Inspection” are not adequate as follows:
a. Your plan associated with your hot-smoked salmon product lists critical limits at the “Hot Smoke/Cook” critical control point that are not adequate to control the “microbiological” hazard, specifically the hazard of Clostridium botulinum toxin formation in your hot-smoked fish product. Your plan lists critical limits of “(b)(4).” FDA recommends firms set critical limits to achieve an internal temperature of fish to be maintained at or above 145° (62.8°C) throughout the fish for at least 30 minutes. Additionally, FDA recommends that firms use equipment capable of continuously monitoring and recording the temperatures for the entire duration of the smoking process to ensure that the listed critical limits are met.
b. Your plan associated with your cold-smoked salmon product:
o lists critical limits at the "Control of temperature and time during smoking process" critical control point that are not adequate to control the "Biological" hazard, specifically the hazard of Clostridium botulinum toxin formation in your cold-smoked salmon product. Your plan lists critical limits of (b)(4). These parameters are not adequate to control the microbiological hazards. Specifically, FDA recommends that the fish not exceed 90°F (32°C) at any time during the cold-smoke process in order to not to reduce spoilage organisms. Spoilage organisms must be present to inhibit the growth and toxin formation of certain strains of Clostridium botulinum.
o does not list any critical limits at the "(b)(4)" critical control point associated with time and temperature to control the microbiological hazard in your cold-smoked fish product. The cold-smoked fish does not receive a heat treatment/kill step to control pathogen growth; consequently, your firm needs to ensure that the fish are held at proper temperatures for the (b)(4). During the inspection, the investigator noted that this (b)(4), depending upon the fillet weight, at (b)(4). FDA recommends that the fish be held at 40° F (4.4° C) or below for the duration of the (b)(4) curing step to control pathogen growth. Additionally, FDA recommends that firms use equipment capable of continuously monitoring and recording the temperatures for the entire duration of the smoking process in the room where the curing occurs to ensure that temperatures do not exceed the listed critical limit.
o lists a chilled maximum critical limit at (b)(4). FDA recommends that refrigerated storage for the cold-smoked product to control pathogen growth should be 4.4°C or less.
3. Predetermined corrective action plans included in a firm's HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective actions detailed in your HACCP plan the “(b)(4) - CCP Summary Sheet January 2013 FDA Inspection” do not include corrective actions that are adequate in that they do not ensure that the cause of the critical limit deviations have been corrected for either your cold-smoked or hot-smoked salmon products.
You should respond in writing within 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 the process flow for your cold-smoked salmon and hot-smoked salmon products, your revised HACCP plans, and five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plans, 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 applicable laws and regulations. Submission of the information in English will assist in our review. 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 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 Good Manufacturing Practice regulation (21 CFR 110). 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 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 foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Denise Beuttenmuller, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Beuttenmuller via email at email@example.com.
Office of Compliance
Center for Food Safety
and Applied Nutrition