Inspections, Compliance, Enforcement, and Criminal Investigations
Green's Fresh Fruit Salad Corporation (dba Salad Chef) 13-Jun-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
June 13, 2008
Mr. Frances Green
President and Owner
Green's Fresh Fruit Salad Corporation
dba Salad Chef
125 Shadeland Avenue
Pleasantville, New Jersey 08232-3623
Dear Mr. Green:
We inspected your seafood processing facility, located at 125 Shadeland Avenue, Pleasantville, New Jersey on January 8, 11; and 15, 2008. 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 ready-to-eat (RTE) seafood salad 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:
I. 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 written HACCP plans to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). 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 does not have a HACCP plan for your ready-to-eat tuna, shrimp, or seafood salads to control the food safety hazards of pathogen growth and toxin formation, nor does your firm have a HACCP plan to control the food safety hazard of histamine formation for your tuna salad.
II. You must maintain sanitation control records that, at a minimum, document monitoring and corrections as set out in 21 CFR 123.11(b), to comply with 123.11(c). However, your firm does not maintain sanitation monitoring records for the sanitation control points (SCPs) applicable to your firm and does not have a sanitation monitoring program in place.
III. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b) However sanitation deficiencies were observed in areas that should have been monitored by your firm, as specified below:
1. You did not monitor the condition and cleanliness of food contact surfaces, as evidenced by the following:
• Employees were observed wiping down processing tables with cloth towels stored in a container of dirty, soapy water containing organic debris. Additionally, no sanitizer was utilized
• An employee was observed slicing onions on a deeply scored and scratched cutting board stained with dark deposits. The onions were intended for use as an ingredient in a ready-to-eat salad.
2. You did not monitor the safety of water that comes into contact with food or food contact surfaces, as evidenced by:
• Potable water spigots with garden hoses attached did not have backflow prevention devices.
I. Your tuna and seafood salads are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] because their labels fail to declare the food allergens egg and Pollock, respectively. Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines milk, egg, fish, crustaceans, shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as "major food allergens." A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
• The word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients (section 403(w)(1)(A) of the Act [21 U.S.C. 343 (w)(1)(A)]; or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list ( unless the name of the food source that appears elsewhere in the ingredient list, appears as part of the name of an ingredient that is not a major food allergen) (section 403(w)(1)(B) of the Act [21 U.S.C. 343(w)(1)(B)]).
The label for your Tuna Salad declares the ingredient mayonnaise. Mayonnaise is a standardized food that contains egg [21 CFR 169.140(c)]. Egg is a major food allergen that is required to be identified on the label. Additionally, our investigators observed that the ingredient declared as "imitation crabmeat" on your Seafood Salad label is made with Pollock. Fish is a major food allergen and the species must be declared on the label. You must ensure that all major food allergen ingredients that may be in your products are declared in the manner required by the Food Allergen Labeling and Consumer Protection Act (FALCPA).
II. Your Tuna Salad and Seafood Salad are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)) in that the label fails to bear the common or usual name of each ingredient. Your products are fabricated using ingredients composed of two or more ingredients; however, the label fails to bear the common or usual name of each,ingredient in the multi component ingredients as required in 21 CFR 101.4(b)(2). For example, the Tuna Salad declares mayonnaise as an ingredient, but does not declare the sub-ingredients, such as eggs and vegetable oils. The Seafood Salad declares imitation crabmeat as an ingredient, but does not declare the sub-ingredients, in part, Pollock and flavors.
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 plan(s) and monitoring 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.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize-your products and/or enjoin your firm from operating in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) and the seafood HACCP regulation.
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 U.S. Food and Drug Administration, Attention: Richard Manney, Compliance Officer, at U.S. Food and Drug Administration, 10 Waterview Boulevard, Parsippany, New Jersey 07054. If you have questions regarding any issues in this letter, please contact Mr. Manney at (973) 331-4908.
Douglas I. Ellsworth
New Jersey District