Inspections, Compliance, Enforcement, and Criminal Investigations
Frank L Harter & Sons Inc 11/1/11
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) 679-2761
November 1, 2011
Via United Parcel Service
Michael F. Harter, Owner
Frank Harter & Sons
3778 Frondorf Avenue
Cincinnati, Ohio 45211
Dear Michael F. Harter:
We inspected your seafood processing facility, located at 3778 Frondorf Avenue on June 27, 29 and July 5, 7, 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, (21 CFR 123). 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). 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 Red Skin Potato, Hawaiian Delight, Three Bean and Pasta Salads and French Onion Dip 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:
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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6 (a) and (b). However, your firm does not have a HACCP plan for your Albacore Tuna Salad and Chunky Tuna Salad to control the food safety hazards of scombrotoxin formation and pathogen growth.
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However your firm did not maintain sanitation monitoring records for the pest exclusion.
Your Red Skin Potato, Hawaiian Delight, and Three Bean Salads and French Onion Dip 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. Specifically:
- Your French Onion Dip fails to declare all ingredients of the original product your firm repackages.
- Your product labels fail to declare the following sub-ingredients of the following multi-component ingredients that are used to manufacture your products:
o Red Skin Potato Salad - salad dressing, sweet pickle relish, iodized salt
o Hawaiian Delight Salad - sour dressing, miniature white marshmallows
o Three Bean Salad - green beans, wax beans, kidney beans
In accordance with 21 CFR 101.4(b)(2), 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.
- The following ingredients were not declared by their common or usual name in accordance with 21 CFR 101.4(a) for the following products:
o Red Skin Potato Salad - The salad dressing used in this product contains high fructose corn syrup; however, you declared the ingredient as “cornsweetener.” The salad dressing also contains disodium calcium EDTA; however, you declared the ingredient as “EDTA.” The sweet pickle relish used in this product contains fructose; however, you declared “sugar” as a sub-ingredient.
o Three Bean Salad - The salad oil used in this product contains partially hydrogenated soybean oil; however, you declared it as “soybean oil.”
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.
We have the following comments about your labels:
1. Your Red Skin Potato Salad and Pasta Salad contains chemical preservatives; however, the labels fail to provide separate descriptions of their functions, e.g. “calcium disodium EDTA (to protect flavor)” or “sodium benzoate (preservative)” in accordance with 21 CFR 101.22(j).
2. Your product labels contain the following ingredients that are not actually in your product:
- Red Skin Potato Salad - alum
- Hawaiian Delight Salad - lecithin, locust bean gum, sodium carbonate & benzoate
- French Onion Dip-non - fat dry milk solids
3. Your Hawaiian Delight Salad and Pasta Salad labels use “contains” statements that fail to completely declare the known major food allergens contained in these products. In accordance with Section 403(w) of the Act when used, the word “Contains,” must be followed by the name of the food source from which the major food allergen is derived. The “contains” statement on your Hawaiian Delight Salad and Pasta Salad labels both fail to declare milk.
4. Your Red Skin Potato, Hawaiian Delight, Three Bean and Pasta Salads and French Onion Dip labels use the abbreviation “WHT” in place of “weight.” In accordance with 21 CFR 101.105(n), the only abbreviation that may be used for “weight” is “wt.”
5. The net weight for your Red Skin Potato, Hawaiian Delight, and Three Bean Salads and French Onion Dip products should be followed by the metric equivalent in parenthesis [21 CFR 101.105(j)(1); 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)]. Your labels only declare net weight in pounds.
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, revised product labels, 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 labeling regulations (21 CFR Part 101). 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: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Compliance Officer Hunter at 513-679-2700 Extension 2134.
Keith J. Jasukaitis
Acting District Director
CC: Charles Kirchner, Chief
Food Safety Division
Ohio Department of Agriculture
895 East Main Street
Reynoldsburg, OH 43068-3399