Inspections, Compliance, Enforcement, and Criminal Investigations
Sunburst Trout Company, LLC 1/11/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
January 11, 2013
Sally C. Eason, CEO/Owner
Sunburst Trout Farms, LLC
128 Raceway Place
Canton, NC 28716-5860
Dear Mrs. Eason:
We inspected your seafood processing facility located at 128 Raceway Place in Canton, NC on July 17-19, 2012. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21 , Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetics Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your smoked 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 regulations, and the Fish and Fishery Products Hazards and Controls Guidance through links in FDA's internet home page at www.fda.gov.
A FORM FDA 483, Inspectional Observations, was issued to Mr. Steven G. Eason on 7/19/2012. We are enclosing a copy of the FDA 483 for your reference. We did not receive a written response to the FDA 483 from your firm. Your significant violations were as follows:
1. You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." We are aware that as a common practice following the brining operation, your firm rinses the fillets with water, then stores the fillets in a cooler for approximately (b)(4) hours prior to conducting your cold smoking operations. Your firm 's HACCP plan for cold smoked trout does not list the critical control point of cooler storage for controlling the food safety hazard of pathogen growth and toxin formation during this in-process cold storage operation. Pathogenic bacteria growth and toxin formation due to time and temperature abuse should be considered a significant hazard at any processing step where a preventative measure is, or can be, used to eliminate the hazard (or reduce the likelihood of its occurrence to an acceptable level) if it is reasonably likely to occur. FDA recommends that you monitor the temperature of the cooler storage on a continuous basis, through the use of a continuous temperature-recording device, with periodic visual checks of the data generated by the device at least once daily.
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 hot smoked trout lists a monitoring procedure frequency at the cooler storage critical control point that is not adequate to control the hazard of pathogenic bacteria growth and toxin formation. Your HACCP plan states that you will monitor the temperature of the cooler (b)(4) on production days and will maintain product temperatures at or below (b)(4) However, FDA recommends that you monitor the temperature of the cooler storage on a continuous basis, through the use of a continuous temperature-recording device, with periodic visual checks of the data generated by the device at least once daily. We are aware that the cooler you use to store your hot smoked fish products is equipped with a temperature recorder chart device. However, review of your temperature recorder chart records, which are meant to capture data for a one week period at a time, revealed that you are not conducting periodic visual checks of the data generated by the device nor are you reviewing the data on a weekly basis. The record review identified at least ten (10) occurrences with time spans of up to four (4) weeks that the recorder chart was not checked or replaced. Your failure to replace the charts on a weekly basis allowed for overlaps of the data. Furthermore, the data revealed that there were at least two (2) occurrences when the cooler temperature exceeded 40°F, with no apparent explanation or corrective actions indicated.
3. 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 cold smoked trout does not list the food safety hazard of pathogenic bacteria growth and toxin formation, specifically Staphylococcus aureus (S. aureus) due to its high salt tolerance, during the dry brining critical control point. S. aureus is of particular concern when competing organisms are inhibited due salting or vacuum packaging operations.
Additionally, your firm's HACCP plan for trout jerky does not list the food safety hazard of pathogenic bacteria growth and toxin formation, such as S. aureus, during the drying critical control point.
4. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your HACCP plan lists verification frequencies that do not ensure that your HACCP plan for cold smoked trout is adequate to control the hazard of pathogen growth and toxin formation. Your HACCP plan indicates that your firm will conduct (b)(4) finished product analysis for water phase salt. However, FDA recommends that you conduct water phase salt analysis of the finished product on a quarterly basis or every three (3) months. Moreover, your firm had no process validation documentation to verify that the critical limits identified in your HACCP plans for cold smoked trout and hot smoked trout, at the brining critical control points, are adequate to provide at least 3.5% water phase salt. FDA recommends that the adequacy of the brining, dry salting, and drying processes be established by a scientific or process validation study, with a record of the process establishment maintained.
We may take further regulatory 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.
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 or have done to correct these violations. You should include in your response documentation such as HACCP and verifications 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 that exist at your facility. You are responsible for ensuring that your seafood processing plant is operating 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.
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 determining 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 reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.
Please send your reply to the U. S. Food and Drug Administration, Attention: Lakisha Morton, Compliance Officer, at 60 - 8th Street NE; Atlanta, GA 30309. If you have any questions regarding any issues in this letter, please contact Mrs. Morton at 404-253-1285.
John R. Gridley
Atlanta District Office