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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

South Side Seafood Inc 4/15/13

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
13-PHI-14
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
April 15, 2013
  
 
Mr. John P. Pazzaglia, Jr.
Vice-President/Partner
South Side Seafood Incorporated
1930 Pittston Avenue
Scranton, PA 18505-3232
 
Dear Mr. Pazzaglia:
 
We inspected your seafood processing facility, located at 1930 Pittston Avenue, Scranton, PA on March 25 through March 26, 2013. 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. 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, the seafood products processed by your facility, including but not limited to ready-to-eat (RTE) pasteurized crabmeat and fresh fin fish 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 and Controls Guidance (the guide) Fourth edition – April 2011, through links in 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 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 written HACCP plan for your ready-to-eat pasteurized crabmeat, and fresh fin fish products to control the food safety hazard of pathogen/toxin formation.
 
We suggest that you use the Fish and Fisheries Products Hazard & Controls Guidance: Fourth Edition to evaluate your firm’s operation regarding seafood products. While the guidance is not a binding set of requirements, it does provide information that will most likely result in a HACCP plan that is acceptable to FDA. Firms may choose other control measures, but they are then responsible for scientifically establishing their adequacy.
 
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 plans, Hazard Analyses, 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.
 
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.
 
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 Fish and Fishery Products (Seafood Hazard Analysis and Critical Control Point - HACCP) regulation, 21 CFR 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.
 
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act. Accordingly, 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)). 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.

Your written response should be sent to Robin M. Rivers, Compliance Officer at the address noted above.  If you have any questions regarding any issues in this letter, please contact Compliance Officer Rivers at 215-717-3076 or e-mail at Robin.Rivers@FDA.HHS.GOV.
 
 
Sincerely,
/S/ 
Kirk D. Sooter
District Director
Philadelphia District
 
 
Enclosure:
     FDA-483 dated March 26, 2013
 
cc: Mr. Carl Pazzaglia, Partner
       South Side Seafood Incorporated
       1930 Pittston Avenue
       Scranton, PA 18505-3232
 
       Pennsylvania State Department of Agriculture
       Bureau of Food Safety and Laboratory Services
       2301 North Cameron Street
       Harrisburg, PA 17110-9408
       Attention: Dr. Lydia Johnson, Director