Inspections, Compliance, Enforcement, and Criminal Investigations
The South Bend Chocolate Company, Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, MI 48207-3179
June 5, 2009
RETURN RECEIPT REQUESTED
Mr. Mark A. Tarner, President
The South Bend Chocolate Company, Inc.
3300 West Sample Street
South Bend, Indiana 46619
On October 14 - 29, 2008 and March 9 – 16, 2009, the Food and Drug Administration (FDA) conducted inspections of your chocolate candy manufacturing facility located at 3300 West Sample Street, South Bend, Indiana. During these inspections, our investigators documented significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110) at your facility. These violations cause the foods manufactured at your facility to be 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), in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, during the March 2009 inspection, we collected labels from some of your products. Our review of those labels found that some of your products are misbranded within the meaning of section 403 of the Act, 21 U.S.C. § 343. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
Current Good Manufacturing Practice Violations
Our inspections of your facility revealed the following violations of the CGMP regulation (21 CFR 110):
1. To comply with section 21 CFR 110.35(c), no pests are allowed in any area of a food plant. Further, effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests.
Our investigators observed the following evidence of a lack of pest control during the inspections:
a. Two dead rodents were observed in the west warehouse (raw materials warehouse). One carcass was on the floor along the wall. Another carcass was observed in an unused sink in a corner of the room. Nesting material was also observed on the floor along the all.
b. Large numbers of rodent excreta pellets were observed throughout the facility. For example, rodent excreta pellets were found: on the floors along walls; on a steel beam traversing the entire length of the building; next to and under pallets containing raw materials for your food products; and near stored in-process candy products, packaging materials and manufacturing equipment.
2. To comply with 21 CFR 110.35(a), buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act. Our investigators observed the following evidence that your facility is not maintained in a sanitary condition or in repair sufficient to prevent food from becoming adulterated:
a. Numerous holes and missing window glass panes in all areas of the building, allowing possible ingress for pests from the exterior of the building to the interior.
b. Numerous holes in building interior walls which could lead to the movement of pests throughout the facility.
3. To comply with 21 CFR 110.20(b)(4), plant buildings and structures shall be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned. However, our investigators observed that your panning room walls are made of wood, and the ceiling in the panning room is a popcorn ceiling. These materials are not easily cleanable and exhibited a buildup of chocolate residue. The buildup of chocolate residue on the popcorn ceiling was located directly over your 3,000 lb. melting tank that is partially open on the top. This could lead to contamination if particles from the ceiling fall into new product as it is being processed.
4. To comply with 21 CFR 110.35(a), cleaning and sanitizing of equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. However, the melting unit on enrober number (b)(4) had reportedly been cleaned but was observed with chunks of old product residue that fell into new product as it was processed.
5. To comply with 21 CFR 110.80, all reasonable precautions must be taken to ensure that production procedures do not contribute to contamination from any source. The production procedures your firm uses in cleaning of equipment are not adequate to ensure that preceding products do not contaminate subsequent products.
a. Your firm uses the cooling tables in the kitchen in the production of products that are formulated to contain major food allergens (“allergenic products”) and products that are not formulated to contain major food allergens (“non-allergenic products”). However, your firm does not use any form of detergent to clean the cooling tables between allergenic and non-allergenic products, but rather uses only a solution of water and a sanitizer (b)(4)). This procedure is insufficient to remove allergenic protein that may be deposited on the cooling tables during production and could lead to cross-contamination of your products with allergens.
b. Your firm uses two enrobing machines and does not dedicate such machines to only allergenic or non-allergenic products. We note your plant manager’s statement that you sequence your product (i.e., run non-allergenic products before allergenic products); however, your firm only scrapes the enrobing machines with a (b)(4) and wipes them with a (b)(4) in between product runs. This procedure is insufficient to remove the allergenic protein that may be deposited on the equipment during production of allergenic products and could lead to cross-contamination of your products with allergens.
We called your firm on March 23, 2009 to advise that our testing isolated Salmonella spp. from one of 221 environmental subsamples FDA collected within your facility. On March 9, 2009 we collected sample INV 522877, Sub 51 from a non-food contact dolly wheel within the warehouse operations area. Salmonella spp. within your facility presents an increased risk to your food production operations and sanitation. Steps should be taken to immediately correct the violations outlined in items 1 and 2 above and to further ensure that your current cleaning and sanitizing programs are effective.
Our review of your labels found that some of your products are misbranded under section 403 of the Act [21 U.S.C. § 343]:
1. Your Sugar Free Assorted Chocolates (5 oz, 8 oz, and 26 oz), Sugar Free/Sucrose-Free Chocolate Covered Peanuts (3 oz and 1lb) and Sugar Free/Sucrose-Free Chocolate Covered Raisins (3 oz and 1 lb) are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] for failing to characterize the level of a nutrient, i.e., sugar/sucrose, in accordance with sugar-free nutrient content claim requirements as specified under 21 CFR 101.60(c)(1). Your products do not appear to qualify for the sugar free/sucrose-free claim. In order to declare that a product is sugar-free, the food must contain less than 0.5g of sugars per reference amount customarily consumed (RACC) and per labeled serving (21 CFR 101.60(c)(1)(i)). The RACC for candies is 40g (21 CFR 101.12(b)), which is also the serving size of these products (21 CFR 101.9(b)(2)). However, these products all declare that they contain “Sugar 3g” per serving, which is greater than the amount permitted in products bearing sugar free claims under 21 CFR 101.60(c)(1)(i).
2. Also, 21 CFR 101.60(c)(1)(iii)(B) requires that sugar free claims are to be immediately accompanied, each time they are used, by one of the following statements: “not a reduced calorie food,” “not a low calorie food,” or “not for weight control.” Some of your products incorrectly place the statement “Not a reduced calorie product” as part of the ingredient statement, but on all of the labels reviewed the products fail to use the disclaimer to immediately accompany the sugar free/sucrose free claims. While the regulations specifically address the nutrient content claim “sugar free”, we note that “sucrose free” is an implied sugar free claim and therefore requires the same immediate disclaimer statement.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. Other violations can subject the food to legal action. It is your responsibility to ensure that your processing plant operates in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure or injunction.
In addition, we have the following comments regarding your product labeling.
Your Nutrition Facts panels do not meet the formatting requirements under 21 CFR 101.9(d).
• Your products fail to set off the nutrition information in a box by use of hairlines (21 CFR 101.9(d)(1)(i)).
• Specific information required in the Nutrition Facts panel (e.g., Serving Size, Servings Per Container, Calories and nutrient information) must not be in a type size smaller than 8 point (21 CFR 101.9(d)(1)(iii)); however, some of your Nutrition Facts information is
in a font size smaller than 6 point.
• The heading must be stated as “Nutrition Facts” rather than “Nutritional Facts” (21 CFR 101.9(d)(2)).
• The nutrients in the nutrition label are not listed in the proper order (i.e., “trans fat” is incorrectly listed after “cholesterol”) (21 CFR 101.9(c)).
• “Sugar” must be declared as “Sugars” (21 CFR 101.9(c)(6)(ii)).
• The serving size declaration (“1.5 oz (40 g)”) is not expressed in common household measure (21 CFR 101.9(b)(5) and 21 CFR 101.12(b)).
Furthermore, please note that in order to display the Nutrition Facts panel in a linear fashion, the foods must be in packages that have a total surface area available to bear labeling of 40 or less square inches (21 CFR 101.9(j)(13)(ii)).
Additionally, your Sugar Free Assorted Chocolate (26 oz) product fails to declare the net weight in both pounds and ounces, e.g., “26 oz (1 lb 10 oz)” (21 CFR 101.105(j)).
All information appearing on the principal display panel or the information panel must appear prominently and conspicuously; however, we note that some of the information on the labels we collected is illegible due to small type size that is less than 1/16 inch (e.g., the net quantity of contents) and due to poor printing quality of the labels (e.g., the net quantity of contents and ingredient information) (21 CFR 101.2(c)).
Finally, the statement “Excess consumption may have a laxative effect” is required on the label and labeling for foods containing mannitol under the conditions stated in 21 CFR 180.25. Your Sugar Free Assorted Chocolates product contains mannitol, but does not bear this statement. In addition, while your Sugar Free/Sucrose-Free Chocolate Covered Peanuts and Sugar Free/Sucrose-Free Chocolate Covered Raisins products, which also contain mannitol, bear a form of the prescribed statement (“This product may have a laxative effect when consumed in large amounts”), it has been improperly included in the ingredient statement.
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 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: LCDR Anastasia M. Piliafas-Brown, Compliance Officer, Detroit District Office, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issues in this letter, please contact LCDR Anastasia M. Piliafas-Brown at 313-393-8270.
Joann M. Givens
Detroit District Office