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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Supreme Manufacturing Company, Inc. 02-Oct-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Waterview Corporate Center
10 Waterview Blvd ., 3rd Floor
Parsippany, NJ 07054



Telephone (973) 526-6008



WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

October 2, 2006

File # 07-NWJ-01

Mr. Clifford Krause
President and Owner
Supreme Manufacturing Company, Inc.
5 Connerty Court
East Brunswick, NJ 08816

Dear Mr. Krause:

On May 22, 23, 24, 31 and June 2, 7, 2006, the Food and Drug Administration (FDA) conducted an inspection of your firm, located at 5 Connerty Court, East Brunswick, New Jersey. The inspection was conducted to determine compliance with FDA's juice hazard analysis critical control point (HACCP) regulations (21 CFR Part 120), FDA's food labeling requirements, (21 CFR Part 101) and the Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food regulations (21 CFR Part 110).

Our inspection found that you have serious deviations from the juice hazard analysis critical control point (HACCP) regulations. In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with that section or otherwise operate in accordance with the requirements of Part 120 renders the juice 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 juice base concentrates are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the juice HACCP regulations through links in FDA's home page at www. fda. gov.

The deviations are as follows:

  • You must have a written HACCP plan to control any food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, your firm does not have a HACCP plan for your 100% orange juice, 100% white grape juice and 100% apple juice concentrate bases, to control the food hazard of pathogens. Furthermore, your firm does not have a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur, and to identify control measures that you can apply to control these hazards as required in 21 CFR 120.7(a), for the 100% orange juice, 100% white grape juice and 100% o apple juice concentrate bases that you process.

  • You must have sanitation control records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation control records at the following sanitation control points:

    1) Safety of water that comes into contact with food or food contact surfaces or is made into ice;
    2) Condition and cleanliness of food contact surfaces;
    3) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces;
    4) Maintenance of hand washing, hand sanitizing, and toilet facilities;
    5) Protection of food, food packaging materials, and food contact surfaces from adulteration with contaminants;
    6) Labeling, storage, and use of toxic compounds;
    7) Control of employee health conditions that could result in contamination of food, food packaging materials, and food contact surfaces;
    8) Exclusion of pests from the facility.

  • You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b). However, your firm failed to monitor sanitation conditions and practices with sufficient frequency, as evidenced by the sanitation deficiencies observed during our inspection at the following sanitation control points: (a) Prevention of cross contamination: product transfer hoses were observed with their ends in direct contact with the floor; the exterior of juice concentrate drums were rinsed with water and subsequently positioned directly over blending vats, allowing for the potential dripping of the rinseate into in-process product; (b) Condition and cleanliness of food contact surfaces: filler hoses were improperly sanitized prior to use; (c) Protection of food, food packaging materials, and food contact surfaces from adulteration with contaminants: plastic ingredient containers were uncovered and encrusted with spillage both on their interior and exterior. Further, bagged ingredients were stored in direct contact with the preservatives stored in open containers, and; (d) Labeling, storage, and use of toxic compounds: bleach and various other cleaners were observed stored in the warehouse directly above food ingredients.

Lastly, during the inspection, labels of your beverage base concentrates were collected. The FDA reviewed your labels for Cherry 100% Concentrate, Clear Cherry 100% Concentrate, Cherry Orange Pineapple 100% Concentrate, Raspberry 100% Concentrate, Blue Raspberry 100% Concentrate and Orange 100% Concentrate. Our review revealed the above products are misbranded under Section 403 of the Act [21 USC 343]. You can find the Act and food labeling regulations through links in FDA's home page at http://www.fda.gov.

The label deviations are as follows:

  • Your Cherry 100% Concentrate and Clear Cherry 100% Concentrate products are misbranded within the meaning of sections 403(a)(1) and 403(i)(1) of the Act [21 USC 343(a)(1) and 343(i)(1)] in that the labels fail to bear the common or usual name of the products and the names on the labels do not accurately declare the flavors of these juice concentrates. Specifically, your products are cherry flavored white grape juice concentrates.

  • Your Cherry Orange Pineapple 100% Concentrate product is misbranded within the meaning of sections 403(a)(1) and 403(i)(1) of the Act [21 USC 343(a)(1) and 343(i)(1] in that the label fails to bear the common or usual name of the product and the name on the label does not accurately declare the flavors of this juice concentrate. Specifically, your product is a cherry, orange, and pineapple flavored white grape juice concentrate.

  • Your Raspberry 100% Concentrate and Blue Raspberry 100% Concentrate products are misbranded within the meaning of sections 403(a)(1) and 403(i)(1) of the Act [21 USC 343(a)(1) and 343(i)(1)] in that the labels fail to bear the common or usual name of the products and the names on the labels do not accurately declare the flavors of these juice concentrates. Specifically, your products are a raspberry flavored white grape juice concentrates.

  • Your Orange 100% Concentrate product is misbranded within the meaning of section 403(a)(1) and 403(i)(1) of the Act [21 USC 343(a)(1) and 343(i)(1)] in that the label fails to bear the common or usual name of the product and the name on the label does not accurately declare the flavors of this juice concentrate. Specifically, your product is an orange flavored white grape juice concentrate.

FDA has regulations that govern the labeling of foods whenever the label makes any representation or designation of the type of flavor(s) in a food, other than in the ingredient statement. You should look to FDA's regulations to determine how to properly describe your product in the statement of identity. If a food contains no artificial flavor that simulates the characterizing flavor, then the name for the food on the principal display panel must simply be accompanied by the common or usual name of the characterizing flavor [21 CFR 101.22(i)(1)]. However, different rules apply if the characterizing flavors are derived from artificial flavors. When artificial flavors are used, the name of the food must be accompanied by the name of the characterizing flavors and the word(s) "artificial" or "artificially flavored" [21 CFR 101.22(i)(2)].

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.

For your information, the above products are labeled with 100% percent juice declaration. However, the juice declaration is not clearly stated as a total percentage juice statement. Concentrated juice products must bear a percentage juice declaration and that declaration may not be greater than 100 percent. The label may explain that when the product is diluted according to label directions, the product yields a "_ percent juice from concentrate," with the blank being filled in with the correct percentage based on the Brix values set out in 21 CFR 101.30(h)(1), as applicable.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these deviations. You should include in your response documentation such as revised HACCP plan(s), revised labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining deviations.

This letter may not list all deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act, the juice HACCP regulations, the Current Good Manufacturing Practice regulations and FDA's food labeling requirements. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Your response to this letter should be directed to the U.S. Food and Drug Administration, Attention: Richard D. Manney, Compliance Officer at the address and telephone number listed above.

Sincerely,

/S/


Douglas I. Ellsworth
District Director
New Jersey District