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WARNING LETTER

Schafer Fisheries Feb 06, 2014

Schafer Fisheries - 02/06/2014


Recipient:
Schafer Fisheries


United States

Issuing Office:
Chicago District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863 

 

February 6, 2014
 
WARNING LETTER
 
CHI-3-14
 
 
DELIVERED VIA UPS NEXT DAY
 
Mr. Michael J. Schafer
Owner
Schafer Fisheries
21985 Waller Road
Fulton, Illinois 61252
 
 
Dear Mr. Schafer:
 
We inspected your processing facilities, located at 21985 Waller Road in Fulton, IL, on August 22 & 26, 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). 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). 
 
We acknowledge receipt of your response to the inspectional findings, sent via email on September 13, 2013. Review of the response revealed continuing concerns as further described in this letter.
 
Accordingly, your fish franks, fish salami and gefilte fish are adulterated, in that they have been prepared, packed, or held under unsanitary 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 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for fish franks, fish salami and gefilte fish, provided with your October 29th response, does not list the food safety hazards of Clostridium botulinum growth and toxin formation and undeclared allergens.
 
a.    Clostridium botulinum growth and toxin formation is a hazard reasonably likely to occur in your products because your packaging materials are oxygen impermeable.  Oxygen impermeable packaging creates anaerobic conditions conducive to toxin formation. We acknowledge that your firm referenced Clostridium botulinum in supporting documentation provided with your October 29th response; however, this specific pathogen is not identified in your HACCP plan and the plan does not include adequate controls.  FDA recommends that once identified as a hazard in the HACCP plan that firms adopt an adequate control strategy, in addition to refrigeration, to prevent toxin formation in each package. For example, FDA recommends adopting one of the following control strategies in addition to refrigeration at 40ºF or less:
                                                             
i.    Controlling the pH of the finished product to be 5.0 or less
ii.    Controlling the water activity of the finished product to be 0.97 or less
iii.    Controlling the water phase salt content in the finished product to be 5% or more
iv.    Using packaging that has an oxygen transmission rate of 10,000 cc/ m2/24 hours at 24ºC
 
b.    Undeclared allergens are a reasonably likely hazard because fish has been identified as one of the eight major allergens. Your firm needs to ensure, through controls listed in your HACCP plan, that finished product labels include all major food allergens, including the specific fish ingredients. 
 
2.    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 fish franks, fish salami and gefilte fish lists critical limits at the cooking and cooling critical control points that are not adequate to control the hazard of pathogen growth and toxin formation.
We make 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.
 
a.    At the critical control point of cooking, the current critical limits listed as “(b)(4) log lethality for Salmonella. Note that no time measurement is necessary if the product internal temperature reaches (b)(4) or higher” are not adequate to control the hazard of pathogen growth and toxin formation. We recommend a critical limit that ensures a heating process that generates a 6D log reduction for Listeria monocytogenes, a pathogen referenced in your supporting documentation. We recommend Listeria monocytogenes as the target organism in your plan because it is the most heat resistant pathogen of concern in ready-to-eat fish products. We further recommend monitoring the critical limits under worse case conditions, such as with a temperature probe located in the thickest part of the largest and coldest fish (i.e., lowest initial temperature) located in the coldest part of the cooker. We further recommend continuous monitoring and recording of the time and temperature for the entire duration of the cook cycle.
 
b.    At the critical control point of cooling, the current critical limits listed as “(b)(4) in no more than (b)(4) hours, and from (b)(4) F in no more than an additional (b)(4)” are not adequate because the time limits are too long and/or the target temperatures are too high to adequately control pathogen growth and toxin formation as a result of post cook time and temperature abuse. We recommend critical limits that ensure cooling parameters that achieve a cooling rate of 57.2°C (135°F) to 21.1°C (70°F) within 2 hours and from 21.2°C (70°F) to 4.4°C (40°F) within an addition 4 hours. Additionally, FDA recommends monitoring internal temperatures of the product, using a frequency adequate to assure and demonstrate that these recommended critical limits are met.
 
We make 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 actions you are taking 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 violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations (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. 
 
Lastly, 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: Rosemary Sexton, Compliance Officer, 550 W. Jackson Blvd., Suite 1500, Chicago, IL 60661. Refer to the Unique Identification Number (CMS Case # 414713) when replying. If you have questions regarding any issues in this letter, please contact Ms. Sexton at (312) 596-4225 or rosemary.sexton@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Scott J. MacIntire
District Director

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