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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Portland Fish Exchange 3/28/14

  

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

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
WARNING LETTER
 
CMS #423361
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
March 28, 2014
 
Raymond Swenton, Board President
Portland Fish Exchange
6 Portland Fish Pier
Portland, ME 04101-4620                                                                
 
Dear Mr. Swenton:
 
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, located at 6 Portland Fish Pier, Portland, ME on February 25 and March 6, 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 seafood products, including histamine producing seafood such as mackerel, bluefish and tuna, 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 violations 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, your firm’s HACCP plan for scombroid species lists critical limits at the receiving CCP that are not adequate to control the scombrotoxin formation (histamine) hazard.  Your critical limits are listed as: “(b)(4)”. During the inspection we noted that your firm is not performing a sensory exam on any incoming scombroid species.   
 
2.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plan for scombroid species does not list monitoring procedures at the receiving critical control point to control the Scombrotoxin formation (histamine) hazard. Your critical limit lists (b)(4), but your plan does not describe how these records will be monitored at the receiving step.  During the inspection, we noted that you are completing records entitled “Vessel Harvest Record for Scombroid Species” and not obtaining required information from the harvest vessel. For example, your records do not provide any information to ensure that incoming fish were properly handled onboard the harvest vessel, such as the rapid chilling of fish immediately after death, controlling onboard refrigeration and performing proper onboard icing.   
 
3.    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 does not record monitoring observations at the receiving critical control point to control the scombrotoxin formation (histamine) hazard.   During the inspection we observed that your firm did not have any monitoring records to demonstrate that the internal temperature of mackerel was recorded upon receipt for (b)(4) out of (b)(4) shipments. We also observed missing records for the receipt of bluefish and tuna on at least 4 occasions.
 
4.    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 monitoring records (for the condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, and the exclusion of pests;) that are required for the processing of seafood. We noted that sanitation records were not maintained by your firm for at least 8 months (June 5, 2012 to the time of the inspection).  
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
You should respond in writing within fifteen (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.
 
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.
 
Please send your reply to the Food and Drug Administration, Attention: Karen N. Archdeacon, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.
 
 
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District Office
 
 
Cc:      
Lambertus Jongerden, General Manager
Portland Fish Exchange
6 Portland Fish Pier
Portland, ME 04101-4620