| | |
 Department of Health and Human Services
| Public Health Service
Food and Drug Administration |
| | Cincinnati District Office
6751 Steger Dr.
Cincinnati, OH 45237
|
VIA United Parcel Service
April 13, 2011
Chad J. Schindler, President
Schindler’s Broad Run Cheese House, Inc.
6011 Old Route 39 NW
Dover, OH 44622-7788
WARNING LETTER CIN-11-158892-08
Dear Mr. Schindler:
We inspected your cheese manufacturing facility, located at 6011 Old Route 39 NW, Dover, OH on September 22 – October 13, 2010 and December 16, 2010. Our inspection found that you have serious deviations of Title 21 of the
Code of Federal Regulations, Part 110 (21 CFR 110), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food. Because your swiss cheese has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby they may have been rendered injurious to health, your swiss cheese is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)]. In addition, we have reviewed the product labels for your swiss cheese and have determined that the product is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations in 21 CFR Parts 101 and 133. You may find the Act and related regulations via links in FDA's home page at
www.fda.gov.
CGMP Violations
During the inspection, we found several CGMP violations at your firm. For example:
1. Buildings fixtures and other physical facilities of the plant must be maintained in a sanitary condition and must be kept in repair sufficient to prevent food from becoming adulterated, and cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against the contamination of food, food contact surfaces, or food packaging materials, in order to comply with 21 CFR 110.35(a). However your firm failed to comply as evidenced by the following:
• On September 22, 2010, the president of the firm poured an unmeasured amount of a red liquid, purported to be acid cleaner, from an unlabeled jug directly into the balance tank. Caustic cleaner from the CIP pasteurizer was drained directly onto the floor while cheese was present in the processing room;
• Employees were dipping and washing utensils into grey murky colored wash water, and no sanitizer was observed in use at the time;
• A reddish slimy substance, along with what appeared to be black mold, was observed on the inside of both brine tanks that were holding in-process cheese;
• The walls surrounding the fixed brine tank containing uncovered 200 pound blocks of cheese exhibit chipped cement and paint peeling off the cement; and
• The ceiling in the brine room exhibits what appeared to be black mold and condensate above the brine tanks containing uncovered 200 pound blocks of cheese.
2. Hand washing facilities must be adequate and convenient by providing, for example, effective hand-cleaning and sanitizing preparations, to comply with 21 CFR 110.37(e). However your firm failed to provide effective hand-cleaning and sanitizing preparations. Specifically:
• There was no soap at the hand washing sink in the repackaging area and no soap at sinks in the employee restroom; and
• On September 22, 2010 an employee working in the cheese make room was scrubbing hands with a green pad at the utensil sink in the water intended for cleaning utensils. The green scrubbing pad was also used to clean cheese making utensils at this sink.
We acknowledge your corrections observed December 16, 2010. Personal items were being stored in provided lockers. Flies were no longer observed in your plant. Acid cleaner and other chemicals repacked from bulk chemicals were properly labeled. Hand washing signs were applied to paper towel dispensers at the three hand washing stations located throughout the processing areas.
Misbranding
1. Your swiss cheese is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare the major food allergen, milk, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as major food allergens 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:
A) 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
B) 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 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 from which the major food allergen is derived 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).
Your swiss cheese is made using milk. However, your label does not declare the presence of milk. Further guidance and information on food allergens can be accessed on FDA’s website at
http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
2. Your swiss cheese is misbranded within the meaning of section 403(g)(1) of the Act [21 U.S.C. § 343(g)(1)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulation, but it fails to conform to such definition and standard. Swiss cheese must be at least 60 days old in order to comply with 21 CFR 133.195(a). Your firm routinely ships what you label “Ohio Swiss Cheese” that has not been aged for 60 days.
3. Your swiss cheese is misbranded within the meaning of section 403(e)(1) [21 U.S.C. § 343(e)(1)] in that the label does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
4. Your swiss cheese is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients but the label fails to declare the common or usual name of each ingredient, as required by 21 CFR 101.4. Specifically, your swiss cheese label does not list any ingredients.
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, or by listing the component ingredients without listing the ingredient itself. 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 cheese must comply with sections 403(e), (g), and (i) of the Act, because, among other things, it does not satisfy 21 CFR 101.100(f). For example:
• In order to ship in-process swiss cheese (i.e. that has not completed the required number of days for ageing), such cheese must bear a legible mark showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, to include the placement of a removable tag on each cheese block wrapper or immediate container the statement “Uncured swiss cheese for completion of curing and proper labeling”. Additionally, the removable tag should declare “To be cured and labeled as ‘swiss cheese,’ but if eyes do not form, to be labeled as ‘swiss cheese for manufacturing’” [21 CFR 101.100(f)(1)].
• Furthermore, swiss cheese made from unpasteurized milk must bear a legible mark on the cheese showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each such cheese or its wrapper or immediate container shall be affixed a removable tag reading, “Swiss cheese made from unpasteurized milk. For completion of curing and proper labeling” [21 CFR 101.100(f)(2)].
However, the label for your “Ohio Swiss Cheese” product is placed on the wooden lid of a stack of six individually wrapped blocks of cheese rather than on each block of cheese. While this label provides the date made, the vat number, the weight of each individual block of cheese, and the statement, “Swiss cheese must be 60 days old before reaching consumer,” the label of your product does not meet the specifications in 21 CFR 101.100(f).
This letter is not intended to be an all-inclusive list of deficiencies in your plant and your product label. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, such as seizure or injunction.
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 violations and to prevent similar violations. You should include in your response documentation such as 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 violations.
Your response should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. If you have any questions with regard to this letter, you may contact Karen Gale Sego at (513) 679-2700 extension 164 or via e-mail:
karen.sego@fda.hhs.gov.
Sincerely,
/S/
Teresa C. Thompson
District Director
Cincinnati District
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