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U.S. Department of Health and Human Services

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Enforcement Actions

True Taste, LLC. 1/11/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

January 11, 2013
 
 
WARNING LETTER
 
                                                                                     
CERTIFIED MAIL                                                 
RETURN RECEIPT REQUESTED                                   
Refer to MIN 13 - 10
 
Dimitri Mazia, President and Co-owner
Vlad Shneyderman, Co-owner
Edward Ponomarev, Co-owner
True Taste, LLC
5647 77th Street, Unit 110
Kenosha, Wisconsin 53142
                                                                            
Dear Messrs. Mazia, Shneyderman, and Ponomarev:
 
We inspected your seafood processing facility located at 5647 77th Street, Unit 110, Kenosha, Wisconsin, on October 30, November 1, and 6, 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 and 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). Accordingly, your cold and hot smoked fish, including Vacuum Packed Hot Smoked Mackerel, Vacuum Packed Cold Smoked Mackerel, Vacuum Packed Hot Smoked Whitefish, Vacuum Packed Cold Smoked Whitefish, Vacuum Packed Hot Smoked Rainbow Trout, Vacuum Packed Hot Smoked Lake Trout, and Vacuum Packed Hot Smoked Lake Herring, 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 Fishery Products Hazards & Controls Guidance through links on FDA’s home page at www.fda.gov.
 
Your significant violations were as follows:
 
1.    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 Clostridium botulinum toxin formation when your process for Cold Smoked Mackerel deviated from your critical limit at the (b)(4) critical control point. Specifically, review of (b)(4) laboratory analyses dated November 21, 2011, found (b)(4) at (b)(4)% and (b)(4)%. The minimum required (b)(4) for smoked vacuum packaged fish is (b)(4)%. This batch was shipped to customers with no corrective action performed, and no evaluation was conducted for the safety of product.
 
2.    You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at:
 
A.   The brining step (including time in brine, salt content of brine, and weight of fish in brine) and critical control point to control Clostridium botulinum toxin formation listed in your HACCP plans for your vacuum packed hot and cold smoked fish, including Vacuum Packed Hot Smoked Mackerel Fish, Vacuum Packed Cold Smoked Mackerel Fish, Vacuum Packed Hot Smoked White Fish, Vacuum Packed Hot Smoked Rainbow Trout, Vacuum Packed Hot Smoked Lake Trout, and Vacuum Packed Hot Smoked Lake Herring.   
 
B.   The smoking step (internal fish temperature and time) and critical control point to control pathogenic growth and toxin formation listed in your HACCP plans for your Vacuum Packed Hot Smoked Mackerel Fish, Vacuum Packed Cold Smoked Mackerel Fish, Vacuum Packed Hot Smoked White Fish, Vacuum Packed Hot Smoked Rainbow Trout, Vacuum Packed Hot Smoked Lake Trout, and Vacuum Packed Hot Smoked Lake Herring.
 
C.   The brining and smoking steps’ critical control points of (b)(4) testing of (b)(4) to control Clostridium botulinum toxin formation listed in your HACCP plans for your Vacuum Packed Hot Smoked Mackerel Fish, Vacuum Packed Cold Smoked Mackerel Fish, Vacuum Packed Hot Smoked White Fish, Vacuum Packed Hot Smoked Rainbow Trout, Vacuum Packed Hot Smoked Lake Trout, and Vacuum Packed Hot Smoked Lake Herring.
           
3.    You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). However, your firm does not have a HACCP plan for Cold Smoked Whitefish to control the food safety hazard of Clostridium botulinum.  
 
4.    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:
 
A.   Vacuum Packed Hot Smoked Mackerel Fish, Vacuum Packed Cold Smoked Mackerel Fish, Vacuum Packed Hot Smoked White Fish, Vacuum Packed Hot Smoked Rainbow Trout, Vacuum Packed Hot Smoked Lake Trout, and Vacuum Packed Hot Smoked Lake Herring do not list a critical limit at the Finished Product Storage critical control point to control Clostridium botulinum toxin formation during finished product storage. Specifically, your HACCP plans for your vacuum packed hot and cold smoked fish have a critical limit of “presence of label statement- Refrigerate at or below 38°F”; however, you must have a temperature critical limit of maximum cooler temperature of 40°F to control Clostridium botulinum
 
B.   Vacuum Packed Hot Smoked Mackerel Fish does not list the critical limit of temperature to maintain the product at 40°F or less at the Receiving critical control point to control scombrotoxin formation. 
 
C.   Vacuum Packed Hot Smoked Mackerel Fish and Vacuum Packed Cold Smoked Mackerel Fish do not list the critical limit for time and temperature during processing to control scombrotoxin formation. 
 
5.    You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). However, your firm’s HACCP plans for:
 
A.   Vacuum Packed Cold Smoked Mackerel Fish, Vacuum Packed Hot Smoked Mackerel Fish, Vacuum Packed Hot Smoked Lake Trout, Vacuum Packed Hot Smoked Lake Herring and Vacuum Packed Hot Smoked White Fish do not list the food safety hazard of Clostridium botulinum toxin formation at the smoking and cooler storage critical control points.   
 
B.   Vacuum Packed Hot Smoked Mackerel Fish and Vacuum Packed Hot Smoked Rainbow Trout do not list the food safety hazard of Clostridium botulinum toxin formation at the brining, smoking and cooler storage critical control points.
 
C.   Vacuum Packed Cold Smoked Mackerel Fish and Vacuum Packed Hot Smoked Mackerel Fish do not list the food safety hazard of scombrotoxin formation at the cooler storage critical control point.     
 
6.    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 prevention of cross-contamination from insanitary objects and protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
A.   An employee was observed touching raw fish with gloved hands and then touching cooked/smoked fish with the same gloves.
 
B.   The water hose in the fish processing room that is used to wash the fish and fill the brine bucket was observed lying on the floor with the nozzle touching the ground.
 
C.   A long wooden stick used to stir the water and salt mixture for the brine was sitting directly on the ground in the fish processing room and then was used to mix the brine.
 
D.   Employees were observed leaving and entering the processing area without washing their hands.
 
7.    You must maintain adequate 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 adequate sanitation monitoring records for (1) safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, (2) condition and cleanliness of food contact surfaces, (3) prevention of cross-contamination from insanitary objects, (4) maintenance of hand washing, hand sanitizing, and toilet facilities, (5) protection of food, food packaging material, and food contact surfaces from adulteration, (6) proper labeling, storage and use of toxic chemicals, (7) control of employee health conditions, and (8) exclusion of pests, required for the processing of vacuum packaged hot and cold smoked fish. 
 
Refer to the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, for guidance in determining the appropriate controls for your processing operations. See Chapter 7 for control of scombrotoxin (histamine) formation and Chapter 13 for control of Clostridium botulinum toxin formation. 
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
 
Claims were noted on your product labeling. Review all of your labels to ensure your product labeling is in compliance and that you do not promote your products for conditions that cause your products to be drugs under section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). Refer to 21 CFR 101.13 for Nutrient Content Claims-General Principles and to 21 CFR 101.14 for Health Claims-General Requirements.
 
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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should respond in writing within 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.
 
Please send your reply to the Food and Drug Administration, Attention: Demetria Lueneburg, Compliance Officer, at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Lueneburg at
(612) 758-7210.
                                                         
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District