Inspections, Compliance, Enforcement, and Criminal Investigations
Murvest, Inc. 10-Sep-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
September 10, 2007
John J. Murphy, President
5390 NW 12th Avenue
Fort Lauderdale, FL 33309-3153
Dear Mr. Murphy:
We inspected your seafood processing facility, located at the above address on June 18 and 19, 2007. We found that you have a serious violation 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. § 342(a)(4). Accordingly, your cooked, refrigerated salmon and broccoli pate is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 violation was 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 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 cooked, refrigerated salmon and broccoli pate to control the food safety hazards of pathogen survival, growth, and toxin formation, specifically Clostridium botulinum.
In addition, it was noted on the FDA 483, Inspectional Observations, provided to you at the close of the current. inspection that the temperature of the cooler used by your firm in thawing smoked, frozen, vacuum-packed salmon-a prominent ingredient in your firm's salmon and broccoli pate-is not monitored continuously. This observation constitutes a failure on your firm's part to prevent the adulteration of frozen ingredients during the thawing process-the growth and toxin formation of pathogens, specifically Clostridium botulinum-as required by 21 CFR 110.80(a)(6). Also, no one associated with your firm has completed training in seafood HACCP as required by 21 CFR 123.10.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product 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 this violation. You should include in your response documentation such as a HACCP plan ; 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: Matthew B. Thomaston, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Mr. Thomaston at (407) 475-4728.
Emma R. Singleton
Director, Florida District