Inspections, Compliance, Enforcement, and Criminal Investigations
Sam Rust Seafood Inc. 05-Apr-06
Department of Health and Human Services
Public Health Service
Baltimore District Office
April 5, 2006
RETURN RECEIPT REQUESTED
Robert L. Edmonds, President
Sam Rust Seafood Incorporated
620 Regional Drive
P.O. Box 9760
Hampton, VA 23670
Dear Mr. Edmonds:
We inspected your seafood processing facility, located at 620 Regional Drive, Hampton, Virginia on March 2-3 and March 6-7, 2006. 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 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.) United States Code § 342(a)(4). Accordingly, your seafood products, including herring, vacuum packaged salt cured herring, and herring roe; seafood products packed in hermetically sealed containers (e .g ., glass jars with metal lids), such as: pickled herring, herring in wine, herring in cream, and caviar; and ready to eat seafood products, such as Cajun Krab Dip, Cajun Smoked Salmon Flavored Spread, and Marinated Mussel Salad 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.
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 HACCP plan for vacuumed packaged salt cured herring and seafood products in hermetically sealed containers (glass jars with lids) of pickled herring, herring in wine and herring in cream, to control the food safety hazard of Clostridium botulinum toxin formation. Additionally, your firm does not have a HACCP plan for ready to eat seafood salads, including Cajun Krab Dip, Cajun Smoked Salmon Flavored Spread, and Marinated Mussel Salad, to control the food safety hazard of pathogen growth and toxin formation.
By letter dated February 12, 2003 FDA informed you of a similar violation.
2. You must implement the record keeping system that you listed in your HACCP plan to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations (internal temperature) at the receiving critical control point to control Scombrotoxin formation as listed in your HACCP plan for Histamine Producing Fish (herring and herring roe).
3. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogen growth and toxin formation when your process for pasteurized crabmeat and crabmeat claws deviated from your critical limit at receiving critical control point. For example; on 8/18/04 and 12/15/05, the 40 degrees Fahrenheit critical limit was exceeded at the receiving CCP. There is no documented evidence to show that corrective actions were taken. 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.
We are aware that you made a verbal commitment to correct the observed deficiencies during the inspection. However, you must 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 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.
Please send your reply to the Food and Drug Administration, Attention: Jose R. Hernandez, Compliance Officer, USFDA, 2810 North Parham Road, Suite 160, Richmond, Virginia 23294. If you have questions regarding any issues in this letter, please contact Mr. Hernandez at (804) 747-0124, extension 103.
Baltimore District Director