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
October 26, 2011
UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
William D. Welch, Vice President
Great American Marketing Company
1224 N. Post Oak St., Suite 160B
Houston, TX 77055
Dear Mr. Welch:
We inspected your seafood processing facility, located at 1224 N. Post Oak Rd., Suite 160B, Houston, Texas, on July 12-14 and August 16-18, 2011. 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 tuna salad sandwich 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.
Your significant violations were as follows:
- 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:
a. During the inspection your firm packaged Fresh Choices Tuna Salad sandwiches (5 oz.) in a polypropylene triangle wedge covered by a film with an oxygen transmission rate of (b)(4). FDA considers oxygen permeable packaging to be packaging that has a minimum oxygen transmission rate of 10,000cc/m2/24 hrs. The combination of packaging that you use significantly limits the flow of oxygen and creates conditions that are conducive to Clostridium botulinum growth and toxin formation (i.e., a modified or reduced oxygen package). Consequently C. botulinum growth and toxin formation is a reasonably likely food safety hazard for the tuna salad sandwiches manufactured by your firm.
FDA recommends temperature control during storage and distribution, along with a secondary barrier, to control C. botulinum growth and toxin formation. Secondary barriers may include product formulation factors such as a pH of 5.0 or less, a water activity below 0.97, or a water phase salt level of at least 5%. Chapter 13 of the Fish and Fishery Products Hazards and Controls Guidance lists strategies for controlling C. botulinum growth and toxin formation that can assist you in choosing a method of control most suited to your process.
b. Your tuna salad sandwiches also have an associated histamine hazard. However, your firm’s HACCP plan for this product does not list this hazard.
- 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 tuna salad sandwiches does not list the critical control point of receiving for controlling the food safety hazards of pathogen growth and histamine formation. Although this critical control point is not listed in your HACCP plan, during the inspection management informed our investigator that you do check the temperatures of incoming product upon receipt, with a critical limit of (b)(4). Please be advised that under these circumstances FDA does not consider a critical limit of (b)(4) to be adequate to control the hazards of pathogen growth and histamine formation. Chapters 7 and 12 of the Guide provide guidance for controlling these hazards at the receiving step.
- 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.
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.
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 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 Seri L. Essary, Compliance Officer, FDA Dallas District Office, 4040 N. Central Expressway #300, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Ms. Essary at 214-253-5335 or Seri.Essary@fda.hhs.gov.
Reynaldo R. Rodriguez, Jr.
Dallas District Director