Inspections, Compliance, Enforcement, and Criminal Investigations
Great American Marketing Company 10/26/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
- 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 tuna salad sandwiches titled, “Tuna Salad Sandwich HACCP Plan”, a copy of which was collected during the inspection, does not list all food safety hazards associated with your product:
- 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."
- 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 tuna salad sandwiches:
- Lists a monitoring procedure at the refrigeration critical control point that is not adequate to control pathogens, including C. botulinum, and histamine formation. Your plan lists a monitoring method of manually checking the temperature “(b)(4)”. However, FDA recommends the use of a continuous temperature recording device with a visual check of the recorded data at least once per day.
- Lists a monitoring method for your allergen hazard of visual inspection of your labels (b)(4). However, FDA recommends that finished product labels be compared to your product formula at the beginning of production of each lot of product, and every hour thereafter.
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for tuna salad sandwiches at the refrigeration critical control point to control pathogen growth is not appropriate. An effective corrective action plan must address correcting the cause of the deviation as well as ensuring that unsafe product does not enter commerce. Your corrective action, “Relocate product to adequate cooler”, does not include evaluating the product to determine if it is unsafe for consumption. This corrective action also does not address correcting the cause of the deviation.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of the water that comes into contact with food or food contact surfaces, the condition and cleanliness of food contact surfaces, the protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants, with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
- On 7/13/11, condensation was observed to be dripping onto pallets of bread in the warehouse cooler and in the main production room. This bread is used to produce sandwiches, including tuna salad sandwiches.
- Visibly unclean equipment, including bins that are used to store tuna salad ingredient as well as metal trays, was observed to be stored on the clean equipment storage shelves in the dishwashing area on 7/14/11.
- Your dishwashing machine contained visibly soiled water that was measured to be (b)(4)°F while it was being used to rinse two previously washed and sanitized white plastic bins on 7/14/11.
- Packaging film was observed to be left on the packaging machine during sanitation on 8/17/11, and water was splashing onto it during the sanitation operation.
- Sponges and soiled brushes with tape repairs were observed being used to clean food-contact equipment on 8/17/11. The brushes and sponges were observed being stored in an insanitary manner, touching the wall and in a soiled plastic carton.
- A hose that was being used on 8/17/11 lacked a backflow prevention device.
- On 8/17/11 an employee was observed to spray a footbath in the production area approximately one foot from a sandwich conveyor line, and water and steam from this operation splashed onto the line’s conveyor belt.