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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Castle Cheese, Inc. 7/11/13

  

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

Public Health Service
Food and Drug Administration
 900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
13-PHI-24
 
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
 
 July 11, 2013
 
 
Michelle L. Myrter, President & Co-Owner
Castle Cheese, Inc.
2850 Perry Highway
Slippery Rock, PA 16057-6308
 
Dear Ms. Myrter:
 
The U.S. Food and Drug Administration (FDA) inspected your food facility, located at 2850 Perry Hwy., Slippery Rock, PA, on November 14, 2012 through December 11, 2012. During this inspection, our investigators obtained product labeling and manufacturing records for several of your cheese products -- including your International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese, and (b)(4) 100% Grated Parmesan Cheese products. We have reviewed these labels and found violations of the food labeling regulations, 21 CFR Part 101, that cause your International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese, and (b)(4) 100% Grated Parmesan Cheese products to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Additionally, these products are adulterated within the meaning of section 402(b)(1), 402(b)(2), and 402(b)(4) of the Act [21 U.S.C. § 342(b)(1), 342(b)(2) and 342(b)(4)]. You can find the Act and regulations on FDA’s home page at www.fda.gov.
 
Adulterated Food
 
1. Your International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese and (b)(4) 100% Grated Parmesan Cheese products are adulterated within the meaning of Section 402(b)(1) of the Act [21 U.S.C. § 342(b)(1)] in that valuable constituent has been in whole or in part omitted or abstracted. Specifically, milk has been in part omitted and replaced by (b)(4) and (b)(4). In addition, the processed cheese-like base used to manufacture your International Packing Parmesan Cheese product uses (b)(4) as the fat source, instead of milk fat as required by the standard of identity.
 
2. Your International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese and (b)(4) 100% Grated Parmesan Cheese products are adulterated within the meaning of Section 402(b)(2) of the Act [21 U.S.C. § 342(b)(2)] in that other varieties of cheese have been substituted wholly or in part for the variety of cheese declared on the products’ labels. Specifically:
 
· Your International Packing Parmesan Cheese has been substituted wholly with (b)(4) cheeses.
· Your (b)(4) Romano 100% Grated Cheese has been substituted in part with (b)(4), (b)(4), (b)(4) and (b)(4) cheeses.
· Your (b)(4) 100% Grated Parmesan Cheese has substituted wholly with (b)(4), (b)(4), (b)(4), and (b)(4) cheeses.
 
We acknowledge your response to the Form FDA-483, dated December 21, 2012, which states that your previous Plant Manager was responsible for the substitution of ingredients without authorization, and that this individual’s employment with your firm was terminated in September 2012. However, all of the products noted above were manufactured between the dates of October 2012 through December 2012, after the termination of your Plant Manager.  On November 14, 2012, our investigators asked Mr. George L. Myrter, CEO and Co-owner if he was aware that the firm is substituting a mixture of different cheese products and/or imitation cheese products for real cheese. Mr. Myrter acknowledged that he was. In addition, our investigators asked if there were any products that definitively contained 100% of the labeled cheese product, and were told that only (b)(4) of your Parmesan cheese products definitively contained all parmesan, because this customer requires a hormone free type of Parmesan that you order specifically for them. 
 
Despite the conversation noted above, on December 11, 2012, during the close-out portion of our inspection you and your legal counsel informed our investigators that your firm did not plan to remove any of the distributed products from the marketplace. We acknowledge that your firm briefly halted production, as stated in your December 21, 2012 response; however, your response also asserts that your products were not adulterated. Additionally, your response only addressed taking corrective actions for parmesan cheese and no other real or imitation cheese products that you manufacture, including the Romano cheese product noted above.               
 
3. Your International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese and (b)(4) 100% Grated Parmesan Cheese products are adulterated within the meaning of Section 402(b)(4) of the Act [21 U.S.C. § 342(b)(4)] in that a substance has been added to increase the products’ bulk and weight. Specifically, cellulose and/or starch were used to increase the weight of the cheese base used to manufacture your products.
 
Misbranded Food
 
4. Your International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese, and (b)(4) 100% Grated Parmesan Cheese products are misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that their labeling is false and misleading. Specifically, your product labels declare that the products are parmesan cheese or romano cheese, but they are in fact a mixture of trimmings of various cheeses and other ingredients. In addition, your parmesan cheese products do not contain any parmesan cheese.
 
5. Your (b)(4) Romano 100% Grated Cheese and (b)(4) 100% Grated Parmesan Cheese products are misbranded within the meaning of Section 403(b) [21 U.S.C. § 343(b)] of the Act in that they are offered for sale under the names of “100% Grated Parmesan Cheese” and “Romano 100% Grated Cheese”, but are in fact a mixture of various grated cheeses. 
 
6. Your International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese and (b)(4) 100% Grated Parmesan Cheese products are misbranded under Section 403(g)(1) [21 U.S.C. § 343(g)(1)] of the Act. These products purport to be or are represented as “Parmesan Cheese” and/or “Grated Cheese,” for which definitions and standards of identity have been prescribed in 21 CFR 133.165 and 21 CFR 133.146, respectively. Based on the finished product labels and manufacturing records, these products do not conform to the definitions and standards in that they contain ingredients, which are not permitted by the standards. Specifically,
 
· Your International Packing Parmesan Cheese contains, but not limited to, the following ingredients which are not permitted by the standard for grated and parmesan cheese: (b)(4), (b)(4) and (b)(4).
· Your (b)(4) Romano 100% Grated Cheese contains, but not limited to, the following ingredients that are not permitted by the standard for grated and parmesan cheese: (b)(4), (b)(4), (b)(4) Cheese, (b)(4) Cheese, (b)(4), and (b)(4).
· Your (b)(4) 100% grated Parmesan Cheese contains, but not be limited to, the following ingredients which are not permitted by the standard for grated and parmesan cheese: (b)(4) Cheese, (b)(4) Cheese, (b)(4) Cheese, (b)(4) Cheese, (b)(4) Cheese, (b)(4), and (b)(4).
 
7. Your International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese and (b)(4) 100% Grated Parmesan Cheese products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because they are fabricated from two or more ingredients and the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. For example:
 
· Your International Packing Parmesan Cheese [Lot # (b)(4)] was manufactured using (b)(4) Cheese, (b)(4) Cheese, (b)(4) and (b)(4); however, your finished product label fails to declare these ingredients and their sub-ingredients. In addition, you declare parmesan cheese as an ingredient; however, you do not use parmesan cheese to manufacture your product. 
· Your (b)(4) Romano 100% Grated Cheese product is manufactured using (b)(4) Cheese, (b)(4) Cheese, (b)(4) Cheese, (b)(4) Cheese, (b)(4), and (b)(4); however, your finished product label fails to declare these ingredients and their sub-ingredients. 
· Your “(b)(4) 100% grated Parmesan Cheese, Best By (b)(4)” product is made using (b)(4) Cheese, (b)(4) Cheese, (b)(4) Cheese, (b)(4) Cheese, (b)(4) Cheese, (b)(4), and (b)(4); however, your finished product label fails to declare these ingredients and their sub-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
 
You should take prompt action to correct the violations described above. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
 
In addition to the violations cited above, we have the following comments:
 
· We note that on November 11, 2012, our investigators reviewed records for your Environmental Listeria Monitoring tests from March 22, 2012 through November 9, 2012. These records document that (b)(4) of (b)(4) samples, which were collected from the production area, show positive Listeria test results. Your firm did not perform speciation testing as a follow-up to these results, to determine if Listeria monocytogenes was present in your facility. Further, from March 22, 2012 to November 9, 2012, your firm continued to manufacture imitation and real cheese products in the area where Listeria was detected.    
 
We acknowledge that on November 14, 2012, as stated in your December 21, 2012 response letter, your firm ceased production in the areas of the plant where Listeria had previously been detected, instituted measures to seal the room, and established a protocol for entry, exit, and working in the production room. Additionally, we acknowledge that (b)(4) environmental swabs were collected from the floor surface in the cook room on November 14, 2012, and sent to (b)(4) for microbiological analysis of Listeria species, and that those results were negative. Your response also states that on December 14, 2012, the food contact surfaces for (b)(4) were swabbed and found negative for Coliform, E.coli, Staph, Listeria, as well as yeast and mold. However, your response fails to identify what type of testing was used to determine these negative analytical results. 
 
· Our review of continuous monitoring records for (b)(4) revealed that temperatures in the cooler reached approximately (b)(4)F on (b)(4) occasions, between October 24-31, 2012. Continuous monitoring records for (b)(4) revealed that temperatures in the cooler reached approximately (b)(4)F on (b)(4) occasions, between October 1-31, 2012. During the inspection, our investigators observed real and imitation cheese finished products stored in these coolers. 
 
In addition, the (b)(4) for finished products has no temperature monitoring devices, nor is there any documentation that shows the amount of time products are in this room or the temperature of this room. Our investigators observed real and imitation cheese products stored in this room, during the inspection.
 
Your December 21, 2012 response letter states that your firm thoroughly cooks all of its products and uses preservatives and anti-microbial ingredients in its products, which serve to prevent the rapid growth of undesirable microorganisms regardless of refrigeration. Further, your response states that no undesirable microorganisms have ever been detected in your products. FDA questions this assertion since your firm does not conduct any finished product microbiological testing.   We acknowledge that your response states that in the future your firm plans to develop additional methods to monitor product cooling and ambient temperatures in the staged cooling room. It also states that your firm has begun a quality assurance program that includes taking product temperatures and daily monitoring of (b)(4) and (b)(4). However, we are unable to evaluate these corrections because you failed to provide documentation with your response which demonstrates this correction.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
 
This letter may not list all the violations in your product labeling or at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and all applicable regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA.  
 
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
 
Sincerely,
/S/ 
Kirk Sooter
District Director
Philadelphia District