Inspections, Compliance, Enforcement, and Criminal Investigations
Sunburst Trout Company, LLC 01-Sep-05
Department of Health and Human Services
Public Health Service
Atlanta District Office
September 1, 2005
VIA FEDERAL EXPRESS
Sally C. Eason, Managing Partner
Sunburst Trout Company, LLC
128 Raceway Place
Canton, NC 28716-5860
Dear Mrs. Eason:
On June 7, 9, and 10, 2005, the United States Food and Drug Administration ("FDA") conducted an inspection of your seafood processing facility located at 128 Raceway Place, Canton, North Carolina. During that inspection, our investigator documented serious deviations from the seafood Hazard Analysis and Critical Control Point ("HACCP") regulations, Title 21, Code of Federal Regulations. Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with, or to otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the 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 trout caviar, fresh and hot-smoked trout, marinated smoked trout, cold-smoked trout, trout dip, and trout burgers, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulations through links in FDA's home page at www.fda.gov.
The deviations of concern are as follows:
1 . You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product that you process, to comply with 21 CFR 123.6(a). 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." You also must have and implement a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). However, your firm does not have HACCP plans for marinated smoked trout and coldsmoked trout to control the food safety hazards of pathogen growth and toxin formation as a result of time/temperature abuse, unsafe aquaculture drugs, and/or Clostridium botulinum toxin formation.
2. You must have and implement a HACCP plan that, at a minimum, lists the critical control points for each of the identified food safety hazards, to comply with 21 CFR 123.6(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." However, your firm's HACCP plan for frozen, vacuum-packed caviar does not list the critical control point of "packaging/labeling"' to control the hazard of C. botulinum toxin formation.
Additionally, your HACCP plans for vacuum-packed, hot-smoked trout, refrigerated trout caviar, and smoked trout dip do not list "shipping" as a critical control point to control the hazards of C. botulinum toxin formation and/or pathogen growth and toxin formation.
3. You must have a HACCP plan that, at a minimum, lists the food safety hazards that are likely to occur, to comply with 21 CFR 123.6(c)(1). However, your HACCP plan for hot-smoked trout does not list the hazard of pathogen growth and toxin formation at the "Smoking," "Labeling," and "Finished Product Storage" critical control points.
In addition, your HACCP plan for trout caviar does not list the hazard of C. botulinum toxin formation at the "Cooler Storage" critical control point. This is a hazard that. may affect the caviar that is vacuum-packed but not stored frozen.
4. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CPR 123.6(b). However, your firm did not record monitoring observations at the "Finished Product Storage" and/or "Cooler Storage" critical control points to control the hazards of pathogen growth and/or C. botulinum toxin formation listed in your HACCP plans for fresh/srnoked trout, raw trout burgers, trout caviar, and smoked trout dip. Contrary to what you stated in your HACCP plans, your cooler storage is not equipped with a temperature recording device/chart for continuous temperature monitoring. Also, there is no record documenting that the daily visual check of the cooler temperature is done as required by the HACCP plans for these products.
Additionally, you have no documentation of animal drug usage, which is required by the monitoring procedures listed at the "Receiving" critical control point in your HACCP plan for fresh/smoked trout. Moreover, you have not documented the visual temperature check in accordance with your monitoring procedures listed at the"Smoking" critical control point in your HACCP plan for fresh/smoked trout.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations. For instance, we may recommend that the United States bring a legal action to seize your product(s) and/or enjoin your firm from operating.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation, such as copies of HACCP plans and HACCP monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to Carlos A. Bonnin, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mr. Bonnin at 404-253-1277.
Mary H. Woleske, Director