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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Able Cold Storage & Trucking 3/28/11

  

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

 

                                                                                                         
March 28, 2011
 
 
WARNING LETTER
 
                                                                                     
CERTIFIED MAIL                                                 
RETURN RECEIPT REQUESTED                                    Refer to MIN 11 - 17
 
 
Scott D. Quade
Owner
Able Cold Storage and Trucking
905 First Street
Newport, Minnesota  55055
 
Dear Mr. Quade:
 
We inspected your seafood processing facility located at 905 First Street, Newport, Minnesota, on October 29 - November 15, 2010. 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 smoked uneviscerated fish, smoked ground crayfish, and smoked shrimp 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 on FDA’s home page at www.fda.gov.
 
Your significant violations were 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 to comply with 21 CFR 123.6(a).  However, your firm has not performed a hazard analysis for smoked uneviscerated fish.  FDA considers uneviscerated fish that are over 5 inches in length that have been salt-cured, dried, or smoked, as well as products made from them, to be adulterated.  A hazard analysis would show that your firm should not accept or receive uneviscerated fish that are over 5 inches long. These products are hazardous whether stored at ambient temperature, refrigerated, or frozen, or whether packaged in air, vacuum, or modified atmosphere.
  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 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(a) and (b). However, your firm does not have a HACCP plan for smoked ground crayfish or smoked shrimp to control the food safety hazards of sulfites and pathogens. 
 
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.
 
We note that you also receive other seafood products at refrigerated temperatures. For any seafood products that you receive and hold for distribution, you must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and 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(a) and (b).
 
We also note that you receive refrigerated seafood products from a supplier located in (b)(4) and thus transport time to your firm is in excess of four hours. When conducting your 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, refrigerated transport of seafood products to your firm may be critical in controlling a hazard.  FDA recommends continuously monitoring time and temperatures during refrigerated transport longer than 4 hours to your firm. Monitoring temperatures at receipt is only appropriate when transit times for the products are short, such as when products are in transit less than 4 hours.   
 
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 123) and the Current 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.
 
Please send your reply to Compliance Officer Rebecca L. Caulfield at the address on this letter. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612) 758-7194.
 
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District