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U.S. Department of Health and Human Services

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Enforcement Actions

Guggisberg Cheese, Inc. dba Deutsch Kase Haus 2/23/09

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

WARNING LETTER
10-DET-08 

 

February 23, 2009


Via Federal Express


Mr. Richard Guggisberg, President
Guggisberg Cheese, Inc. dba Deutsch Kase Haus
5060 SR 557
Millersburg, OH 44654


Dear Mr. Guggisberg:

On September 10, 2009 - October 8, 2009 the Food and Drug Administration (FDA) conducted an inspection of your cheese manufacturing facility located at 11275 W. 250 N., Middlebury, IN 46540. During the inspection our investigators collected samples of your product labeling. Our review of your product labels found that some of your products are misbranded within the meaning of sections 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §343] and Title 21, Code of Federal Regulations (CFR) Part 101.


Your "Yogurt Cheese," "Vegetable Yogurt Cheese," and "Butter Cheese" products are misbranded under section 403(i)(1) of the Act [21 U.S.C. § 343 (i)(1)] because these names are not common or usual names, nor appropriately descriptive terms or phrases that describes the basic nature of the foods (21 CFR 101.3 (b)). Yogurt is a food that is defined by a standard of identity in 21 CFR 131.200. Butter is a food that is defined by the Act of March 4, 1923 [21 U.S.C. § 321a]. These terms may not be used in the statement of identity for your products unless one of the ingredients used to make the product conforms to the statutory definition for the term.


Your products "Yogurt Cheese" and "Butter Cheese" are misbranded within the meaning of 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] because the Nutrition Facts are not in accordance with the requirements in 21 CFR 101.9. For example:


• The number of servings per container is not declared [21 CFR 101.9(b)(8)];
• The cholesterol content is not expressed in milligrams to the nearest 5 milligram increment [21 CFR 101.9(c)(3)];
• The sodium content is not expressed in milligrams to the nearest 10 milligram increment [21 CFR 101.9(c)(4)].
 

Additionally, your "Vegetable Yogurt Cheese" product is misbranded within the meaning of 403(q)(1) because the Nutrition Facts are not in accordance with the requirements in 21 CFR 101.9. For example:


• The number of servings per container is not declared [21 CFR 101.9(b)(8)];
• The fat calories are not expressed to the nearest ten calorie increment [21 CFR 101.9(c)(1 )(ii)].


Your "Yogurt Cheese," "Vegetable Yogurt Cheese" and "Butter Cheese" products are further misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to bear the net quantity of contents in accordance with 21 CFR 101.105.


The above violations are not meant to be an all-inclusive list of deficiencies that may occur in your product labeling. 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.


Furthermore, during the inspection our investigators collected environmental swabs on September 14 & 15, 2009. Our investigators issued a form FDA-483, Inspectional Observations, at the close of the inspection, and discussed these observations with you. The observations listed pertain to requirements for current good manufacturing practice (CGMP) in manufacturing, packing, or holding human food (21 CFR 110).


The following insanitary conditions were revealed during the inspection:


Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition sufficient to prevent food from becoming adulterated within the meaning of the act as required by 21 CFR 110.35(a).


On September 14, 2009, our investigators collected sixteen (16) environmental swabs in the cheese cutting room. One swab, taken of an area of floor and pallet containing packaging materials located in the middle of the cheese cutting room, was confirn1ed for presence of Listeria monocytogenes by an FDA laboratory.


On September 15, 2009, our investigators collected nine (9) environmental swabs in the canned raw milk receiving room of which two were confirmed for presence of Listeria monocytogenes by an FDA laboratory. One swab was taken at a trench drain in the floor approximately 12 feet south of the door opening on the north wall The second swab was taken underneath a black rubber mat directly in front of the door on the south wall leading into the production area.

Listeria monocytogenes within your manufacturing facility presents an increased risk of pathogenic contamination to your food production operations and sanitation. Steps should be taken to immediately correct the violations outlined above and to further ensure that your current cleaning and sanitizing programs are effective.


We acknowledge receipt of your October 12, 2009 response to the FDA 483, Inspectional Observations. Your response indicated that training will be held with employees on (b)(4) and that corrective actions in your facility have been implemented or plan on being implemented in the future. We will evaluate the sufficiency of your response at the next scheduled inspection.


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: Catherine V. Quinlan, 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 Ms. Quinlan at (313)-393-8153.


Sincerely, 

/S/
Joann M. Givens
District Director
Detroit District Office


Individual copy sent via Federal Express to:


Mr. Richard L. Bylsma, Director of Sales, Indiana Division
Guggisberg Cheese, Inc. dba Deutsch Kase Haus
11275 W. 250 N.,
Middlebury, IN 46540