Reference HACCP-1 inspection. 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-1 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 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 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.
