Inspections, Compliance, Enforcement, and Criminal Investigations
Barnacle Seafod, Inc. 30-Nov-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
November 30, 2007
Barnacle Seafood, Inc.
James L. Ruos
President and Chief Executive Officer
5301 NW 35th Avenue
Fort Lauderdale, FL 33309-6315
Dear Mr. Ruos:
We inspected your seafood processing facility, located at the, above address on August 6, 7, and 8, 2007. 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. § 342(a)(4). Accordingly, your raw, fresh, refrigerated scombroid species of fish; canned, pasteurized, refrigerated, ready-to-eat crabmeat; refrigerated, ready-to-eat caviar; and smoked, vacuum-packed, refrigerated, ready-to-eat fin 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 regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
On October 3, 2007, we received your firm's response to the FDA 483, Inspectional Observations, issued to and discussed with you at the close of the inspection on August 8, 2007. We consider your firm's response only partially adequate. 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."
• However, your firm's HACCP plan for raw', fresh, refrigerated scombroid fish does not list the critical control point of storage for controlling the food safety hazard of histamine formation.
• However, your~firm's HACCP plans for the following products do not list the critical control point of refrigerated storage for controlling the significant food safety hazards of pathogen growth (particularly, Clostridium botulinum) and associated toxin formation: canned, pasteurized, refrigerated, ready-to-eat crabmeat; refrigerated, ready-to-eat caviar; and smoked, vacuum-packed, refrigerated, ready-to-eat fin fish.
2. 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 canned, pasteurized, refrigerated, ready-to-eat crabmeat; refrigerated, ready-to-eat caviar; and smoked, vacuum-packed, refrigerated, ready-to-eat fin fish does not list the food safety hazard of Clostridium botulinum and toxin formation.
3. Because you chose to include a corrective action pl an in your HACCP plan, your described, corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action pl an for histamine formation at your receiving critical control point does not include such appropriate actions as, investigating the cause of the critical limit deviation, and measures taken to prevent the recurrence of the deviation.
4. You must have a HACCP pl an 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 ready-to-eat products (i.e., canned, pasteurized, refrigerated, ready-to-eat crabmeat; ready-to-eat sushi; refrigerated, ready-to-eat caviar; and smoked, vacuum-packed, refrigerated, ready-to-eat fin fish) lists a monitoring procedure at the "Receiving" critical control point that is not adequate to control pathogen growth and toxin formation.
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 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: 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