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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Freskeeto Frozen Foods Inc 4/18/13


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

Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433 


April 18, 2013
Mr. Gary J. Dickman
President / Co-Owner
Freskeeto Frozen Foods, Inc.                                                
8019 Route 209
P.O. Box 547
Ellenville, NY 12428-5615
Dear Mr. Dickman,
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food warehousing facility, located at 8019 Route 209, Ellenville, NY 12428-5615, from March 5, 2013 through March 11, 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 (21 CFR Part 123). In accordance with 21 C.F.R. 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 vacuum packed smoked salmon and herring in wine 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.
We received your firm’s response dated March 12, 2013, regarding our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to Mr. Scott S. Dickman, Vice President / Co-Owner. We address this response below, after the violations. The violations include, but are not limited to, the following:
  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 C.F.R. 123.6 (a) and (b). However, your firm does not have a HACCP plan for:
  • For receipt of vacuum packed smoked salmon to control the significant hazards of pathogen growth and toxin formation;
  • For receipt and storage of various marinated/pickled herring products to control the significant hazard of scrombrotoxin (histamine) and pathogen growth and toxin formation. Furthermore, this is a repeat observation from your   previous inspection which concluded on August 28, 2012.
Once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply with 21 C.F.R. 123.6(c).  
  1. No one associated with your firm has completed HACCP training or is HACCP qualified through job experience, as required by 21 C.F.R. 123.10.  Furthermore, this is a repeat observation from your previous inspection which concluded on August 28, 2012.
Your response for the aforementioned violations has been made part of the file. In addition, your firm’s promise to correct the violations was also made in your September 4, 2012 response to the Form FDA 483 (FDA 483), List of Inspectional Observations, issued to your firm on August 28, 2012. This timeframe was more than sufficient to adequately correct all the violations.
We do acknowledge that you have taken some proactive steps in monitoring of your seafood products. However, monitoring is not in place at all necessary critical control points (CCP’s), such as product receiving. At a minimum, you should consider inclusion of controls in your HACCP plan at the receipt and/or storage of applicable seafood products to ensure adequate temperatures are observed during product receipt and refrigerated storage. Intermittent temperature checks as a monitoring procedure during extended refrigerated storage is not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks. Furthermore, checking the temperatures exclusively on workdays does not cover temperature monitoring during those days when you are not in operation, for example during weekends, holidays and overnight. FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated storage.   In addition, we recommend a daily check of the recorded temperatures to ensure that proper temperatures have been maintained and a daily check of the monitoring equipment itself to ensure that it is operating properly. 
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 C.F.R. Part 123) and the Current Good Manufacturing Practice regulation (21 C.F.R. 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 reinspection-related costs. A reinspection 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. Reinspection-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.
Your response should be sent to:
LCDR Frank Verni
Compliance Officer
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
If you have any questions about the content of this letter please contact: LCDR Verni at (718) 662-5702.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Ronald M. Pace
District Director
New York District