Inspections, Compliance, Enforcement, and Criminal Investigations
The Sandwich Man, Inc. 11/10/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
November 10, 2011
WARNING LETTER NO. 2012-NOL-04
UNITED PARCEL SERVICE
Delivery Signature Requested
Cheryl A. Lavigne, President
The Sandwich Man, Inc.
65275 Highway 41
Pearl River, Louisiana 70452-5677
Dear Ms. Lavigne:
On May 16-17, and 19, 2011, U.S. Food and Drug Administration (FDA) investigators inspected your seafood processing facility, located at 65275 Highway 41, Pearl River, Louisiana. We found 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 Part 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 which 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 United States Code (USC) 342(a)(4). In addition, our inspection found serious violations of the Current Good Manufacturing Practice (CGMP) regulation that affect all food products manufactured at your facility. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR 110, renders your firm’s products adulterated within the meaning of 402(a)(4) of the Act. Additionally, we have reviewed the labels for your “Shrimp & Crab Salad” and “Tuna Salad” sandwich products and have determined the products are misbranded within the meaning of Section 403 of the Act [21 USC 343]. The Act and FDA’s regulations can be found through links on FDA's Internet home page at www.fda.gov.
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 you produce to determine whether there are food safety hazards which are reasonably likely to occur and have a HACCP plan which, at a minimum, lists the food safety hazards which 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 plans for Shrimp & Crab Salad and Tuna Salad sandwiches do not list the food safety hazards of allergens (fish, soy, eggs, and wheat).
2. You must have a HACCP plan which, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plans for Shrimp & Crab Salad and Tuna Salad sandwiches lists the critical limit, (b)(4), at the (b)(4) and (b)(4) critical control points which is not adequate to control pathogen growth and toxin formation. Products should be maintained at or below (b)(4) while in storage.
We also note the Critical Limit of (b)(4) is listed at the Product Assembly Critical Control Point for these same HACCP Plans. Because the assembly of your sandwiches does not expose the components of that product to temperatures above (b)(4), but below (b)(4), for less than an hour cumulative, this step does not need to be listed as a critical control point in your HACCP plans. However, if you choose to include the Product Assembly Critical Control Point, then your critical limit should be adequate to control pathogen growth and toxin formation.
3. You must have a HACCP plan which, 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 plans for Shrimp & Crab Salad and Tuna Salad sandwiches list a monitoring procedure at the (b)(4) critical control point which is not adequate to control Pathogen growth. Although you use a temperature indicating alarm, FDA recommends a continuous temperature recording device with visual checks at least once per day to monitor the temperature of the cooler.
1. Effective measures must be taken to exclude pests from the processing areas, to comply with 21 CFR 110.35(c). However, ants and other insects were observed in the kitchen area during our inspection.
2. Your employees must wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable organisms) in an adequate hand-washing facility after each absence from the work station and any time their hands may have become soiled or contaminated, to comply with 21 CFR 110.10(b)(3). However, the following was observed during our inspection:
a. One employee was observed using a paper towel which was previously in the trash can to wipe their hands and then touched sandwiches without washing or sanitizing their hands; and,
b. Employees were observed not washing their hands after touching unsanitized objects.
During the FDA inspection, investigators collected environmental samples from various areas in your facility. Three environmental swabs tested positive for Listeria monocytogenes (L. monocytogenes). L. monocytogenes is a pathogenic bacterium which is widespread in the environment. It can proliferate in food processing facilities without proper controls. L. monocytogenes can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening illness called invasive listeriosis. Listeriosis is an atypical foodborne illness of major public health concern because of the severity of the disease, a high case-fatality rate, a long incubation and a predilection for individuals with underlying conditions.
Bacteria may enter and/or be transported through a food plant by a variety of routes which include, but are not limited to: roof leaks; the shoes of employees, contractors, and visitors; the wheels of fork lifts, pallet movers, and moveable equipment; soiled pallets; soiled raw material packaging; raw ingredients; and, rodent vectors. Once established on production area floors, the pathogen may contaminate food and food-contact surfaces through either human or mechanical means. L. monocytogenes differs from most other foodborne pathogens because it is widely distributed, resistant to diverse environmental conditions, including low pH and high NaCl concentrations, and grows under refrigeration conditions.
The aforementioned environmental swabs were taken from puddles of standing water on the floor in front of your freezer and cooler and the wheel on the sandwich slicing machine in the production area. The presence of L. monocytogenes in more than one location within your facility indicates that L. monocytogenes may have become established in a niche environment in your facility. The presence of L. monocytogenes on the wheels of a slicer is of particular concern as the organism could likely spread when the slicer moves throughout the facility, and because of the close proximity to where food is exposed. Therefore, based on our analytical and inspection findings, the food products manufactured at your facility are adulterated within the meaning of Section 402(a)(4) of the Act, because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health.
It is essential to identify the areas of your facility where L. monocytogenes is able to grow and survive (niche areas) and to take such corrective actions as necessary to control the organism. Adequate sanitation controls should include effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L. monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination.
During the inspection, our investigator collected labels for several of your products. Our review of the labels and other evidence collected during the inspection found deviations from the labeling regulations that cause your Shrimp & Crab Salad and Tuna Salad sandwich products to be misbranded within the meaning of Section 403 of the Act [21 USC 343].
Your Shrimp & Crab Salad sandwich is misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)] because the product statement of identity is false and misleading. The ingredient statement for the product states the product is manufactured with imitation crab meat; however, the statement of identity indicates the product is made with crab meat.
Your Shrimp & Crab Salad and Tuna Salad sandwich products are misbranded within the meaning of Section 403(w) of the Act [21 USC 343(w)] because the label fails to declare the major food allergens, fish and milk, as required by Section 403(w)(1) of the Act [21 USC 343(w)(1)].
Section 201(qq) of the Act [21 USC 321(qq)] defines “major food allergens” as milk, egg, fish, Crustacean 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. 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:
i. 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 USC 343(w)(1)(A)], or;
ii. 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 [e.g., “flour (wheat)”], except that 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 USC 343(w)(1)(B)].
Fish: Your Shrimp & Crab Salad sandwich product is manufactured using imitation crab meat which according to the ingredient statement contains “pollock and/or whiting”, but you fail to declare the allergen and the specific species on the finished product label.
Milk: Your Shrimp & Crab Salad and Tuna Salad sandwich products both declare “whey” in the ingredient statement; however, you fail to declare the major allergen milk, from which the ingredient is derived.
Your Shrimp & Crab Salad and Tuna Salad sandwich products are misbranded within the meaning of Section 403(i)(2) of the Act [21 USC 343(i)(2)] because they are fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight, as well as all sub-ingredients, as required by 21 CFR 101.4 as follows:
• The (b)(4) you use to manufacture your Tuna Salad sandwich, list water, vegetable broth, salt and soy as ingredients on the label of the product; however, you fail to list the ingredients on your finished product label.
• The imitation crabmeat used as an ingredient to manufacture your Shrimp & Crab Salad sandwich, list fish, water, corn starch, wheat starch, sugar, natural and artificial flavor, egg whites, potato starch, soybean oil, salt, sorbitol, modified food starch, sodium phosphates, paprika, and color as ingredients on the label of the product; however, you fail to list them as ingredients on your finished product label.
• The ingredient statement for both products declare “B Vitamins” and “High Fructose Corn Syrup or Sugars” within the sub-ingredients of the bread component. The regulations do not allow the collective listing of vitamins nor does it allow for the use of the term “and/or” for sweeteners. The ingredient statement should be an accurate list of only the ingredients used in the product’s manufacture.
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 [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 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.
Your Shrimp & Crab Salad and Tuna Salad sandwich products are also misbranded within the meaning of Section 403(k) of the Act [21 USC 343(k)] because the products bear or contain a chemical preservative, but the function is not declared on the label. In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative has been added shall bear a declaration of both the common or usual name of the ingredient and a separate description of its function, e.g. “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”. The ingredient statement for your Shrimp & Crab Salad sandwich product declare the presence of calcium propionate and your Tuna Salad sandwich declares the presence of calcium propionate and potassium sorbate but fail to provide a separate description of the function of these ingredients as required.
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. 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, and should include documentation such as your revised HACCP plans, revised 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 also offers you an opportunity to meet with the FDA New Orleans District staff. We believe a meeting may assist you in resolving your firm’s lack of compliance with federal regulations. A meeting would provide an opportunity for you to present any questions you may have regarding the implementation of corrections and for the FDA to provide guidance and sources of training to assist you in achieving full compliance.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the CGMP regulation (21 CFR 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: Mark W. Rivero at the above address. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1290, extension 1103.
Kimberly L. McMillan
Acting District Director
New Orleans District
Form FDA 483 dated May 19, 2011