Inspections, Compliance, Enforcement, and Criminal Investigations
Tri-County Food Service & Distribution Inc 9/21/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
Via United Parcel Service
September 21, 2010
Randy J. Hall, Co-Owner
Tri-County Food Service & Distribution, Inc.
11371 Williamson Rd.
Cincinnati, OH 45241
Dear Mr. Hall:
We inspected your food processing facility, located at 11371 Williamson Rd., Cincinnati, OH 45241 on June, 8,9, 17,30, 2010. 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 and fish (Cod) sandwiches 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.
In addition, during the inspection, labels for your Fish Hoagie, Tuna Salad Croissant, and Tuna & Noodles products were collected. We have reviewed your labels and find that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
Your significant violations were as follows:
Seafood HACCP Violations:
Each processor shall have implemented a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur. The plan may group kinds of fish and fishery products together or group kinds of product methods together, in accordance with 21 CFR 123.6 (b)(2) when the food safety hazards, critical control points, critical limits and procedures required to be identified and performed are identical. However your firm does not have separate HACCP plans for your tuna salad sandwich product line and your cooked fish sandwich to control the food safety hazard[s] of histamine formation and pathogen growth and survival. The product lines are sufficiently different to necessitate separate control strategies for the hazards associated with each type of sandwich.
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 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 current HACCP plan (titled Tri County Food Service Control Strategy and dated 8/25/09) for Tuna Salad [production of tuna salad, tuna sandwich preparation and finished product storage] does not list the food safety hazard of scombrotoxin (histamine) formation at the Production of Tuna Salad CCP and the Tuna Sandwich Preparation CCP. This HACCP plan which also covers the production of Cooked Fish Sandwich Preparation does not list the food safety hazard of Pathogen Survival at the Cooking of Fish CCP.
2. 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 which, 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, titled "Tri County Food Service Control Strategy" and dated 8/25/09, does not list a critical control point to control
• pathogen growth hazard at the rapid cooling (post cook) step for your cooked fish sandwich production process, and
• histamine formation hazard at the overnight storage of tuna salad product.
3. You must implement the record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations or values at the "Cooking of Fish" critical control point to control pathogen growth listed in your HACCP plan for fish (cod) sandwiches. You have not documented the cook temperature or time as your plan states you will do via "MIG temp check and timer" at a frequency of "every batch".
4. Because you choose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate to the deviation to comply with 21 CFR 123.7 (b). However, your corrective action plans, covering the hazard "Pathogen Growth" for the Production of Tuna Salad, Tuna Sandwich Preparation, Fish Sandwich Preparation and Finished Product Storage do not establish the steps, e.g. a time and temperature evaluation, necessary to evaluate and ensure no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. Additionally, the corrective action plans do not address correcting the cause of the deviation.
5. 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 prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product [123.11(b)(3)] with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110] as evidenced by:
o On 6/8/10, we observed an employee wearing gloves break down a cardboard box, left the kitchen area using door handle, reenter the kitchen, put his glasses on, wrote on a clipboard, and began preparing meat patty sandwiches with no change of gloves and no hand washing.
o On 6/8/10, we observed a separate employee enter the kitchen and briefly wash her hands in the 3 compartment sink, wipe her table with a rag from a bucket of utensils with chlorine water, move a rack of food, put on gloves, get bread out from a food rack, dip her hands in the utensil bucket, wipe down a knife, grab a scale and began preparing sandwiches.
o 7 of 8 kitchen employees were observed wearing street clothes and not wearing outer clothes or garments. The eighth employee was wearing an apron and left the kitchen several times without removing the apron.
• 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:
o On 6/8/10, we observed another employee not wearing gloves pick up a tray of food, leave the kitchen to place the tray in the freezer, reenter the kitchen, wipe down his work station with a rag from a bucket of utensils with chlorine water, and pull out croissants to begin preparations for sandwiches.
o On 6/8/10, we observed the cleaning of food preparation utensils. An employee rinsed the utensils, put the utensils in a container of soap and water, wiped them down, rinsed and placed the objects in the 3rd compartment of the 3 compartment sink to dry. No sanitizer was present or used. This employee continued this procedure for the mixing bowls.
o A coffee pot and open sugar containers were observed in the kitchen. This coffee is prepared and used by employees and truck drivers.
o Employees were observed using the kitchen microwave to reheat personal food.
o 3 employees with goatees were in the kitchen without beard covers.
o On 6/8/10, we observed two employees wearing arm bracelets and one employee wearing earrings.
o On 6/8/10, an employee explained that the containers kept at the food preparation tables were prepared with 2 capfuls of bleach for approximately 1 gallon of water. According to the firms Sanitation Procedures each work station must have sanitizer in a container with a ratio of bleach sanitizer as 50-100ppm. The procedure also states to use test strips and refresh as needed. The firm did not have test strips on hand. The sanitizer solution tested with ratio of bleach sanitizer above 200ppm.
Your fish hoagie, tuna and noodles, and tuna salad croissant products are misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] because these products are fabricated from two or more ingredients and each ingredient is not declared on the label as required by 21 CFR 101.4(b). For example:
•The ingredient statement for your fish hoagie declares "Enriched Flour: flour, niacin, iron, thiamine hydrochloride, riboflavin" but does not include folic acid.
•Your Tuna Salad Croissant label declares "Enriched Flour" but fails to include all of the subingredients of enriched flour.
Enriched Flour is a food for which a standard of identity has been established in 21 CFR 137.165 and contains wheat flour, niacin, iron, thiamin, riboflavin, and folic acid. If your products contain enriched flour, you must declare all of the ingredients in the enriched flour as required.
•Your Tuna Salad Croissant and Tuna and Noodles labels declare "vegetable oil" but fail to identify the specific fat and/or oil ingredient by its common or usual name (e.g. soybean oil) as required [21 CFR 101.4(b)(14)].
•Your Tuna & Noodles product lists the ingredient "Dried Dairy Blend," which is not a common or usual name as required in 21 CFR 101.4.
•The Tuna Salad Croissant and Tuna Salad labels lists the ingredient "alum," which is not the common or usual name for this ingredient as required in 21 CFR 101.4.
The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
Additional CFSAN Comments:
• During our label review we noted that your fish hoagie product does not contain the name and place of business of the manufacturer, packer, or distributor on the label in accordance with 21 CFR 101.5(a).
• We also noted that the food additive FD&C Yellow #5 is listed on all other tuna products except your Tuna & Noodles product. We did not know if this was an oversight in not properly declaring FD&C Yellow #5, in this product; or if the Tuna & Noodles product actually did not contain FD&C Yellow #5.
• We note that some of the mandatory information on your labels is overlapping, punctuation is missing, and the printing quality appears to be poor (e.g., some of the letters in the Fish Hoagie ingredient statement are illegible). All information appearing on the principal display panel must appear prominently and conspicuously to comply with 21 CFR 101.2(c).
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. 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.
Please send your reply to the Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Ms. Hunter at 513-679-2700, Ext. 134, or at email@example.com.
Teresa C. Thompson
Cc: Charles Kirchner, Chief
Food Safety Division
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399