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  5. Agrovillaserra, S.L. - 11/05/2014
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WARNING LETTER

Agrovillaserra, S.L. Nov 05, 2014

Agrovillaserra, S.L. - 11/05/2014


Recipient:
Agrovillaserra, S.L.


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

NOV 5, 2014

WARNING LETTER                                      
 
 
VIA EXPRESS DELIVERY
 
Mr. Antonio Villajos-Serrano, Director
Agrovillaserra, S.L.
Calle Real, 43
Porzuna, Ciudad Real
Castilla de la Mancha, Spain 13120
 
Re: 440603
 
Dear Mr. Antonio Villajos-Serrano:
 
The United States Food and Drug Administration (FDA) inspected your facility, Agrovillaserra S.L., located in Castilla de la Mancha, Spain, on May 26, 2014. The inspection was conducted to determine your compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and regulations that apply to the food you ship to the United States. Based on our review, we have concluded that your Villagios Artisan Manchego Cheese and Villagos Manchego Cheese products are in violation of the Act and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and these regulations through links in FDA’s home page at www.fda.gov.
 
1.    Your Villagos Artisan Manchego Cheese product is misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, eggs, as required by section 403(w)(1) of the Act. Specifically, your Villagos Artisan Manchego Cheese product is manufactured using egg lysozyme that contains eggs.
 
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines 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 as “major food allergens.” A food is misbranded under section 403(w) of the Act 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: 
  • 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
  • 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 (e.g., “Whey (Milk)”), except 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 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)].
2.    Your Villagos Artisan Manchego Cheese and Villagos Manchego Cheese products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to bear nutrition  information as required by 21 CFR 101.9.
 
Your products both have expired Small Business Nutrition Labeling Exemption notifications. Section 403(q) of the Federal Food, Drug, and Cosmetic Act requires that packaged foods bear nutrition labeling information unless you qualify for an exemption. However, if any nutrient content claim (e.g. antioxidant), health claim, or other nutrition information is provided on the label, or in labeling or advertising, the small business exemption is not applicable for a product. Further guidance and information on food labeling can be accessed on FDA’s website at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm2006828.htm.
 
3.    Your Villagos Artisan Manchego Cheese product is misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example, your Villagos Artisan Manchego Cheese product is manufactured using egg lysozyme; however, you fail to list this ingredient on your finished product label.
 
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported cheese products under Section 801(a) of the Act [21 U.S.C. § 381(a)], including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the allergen labeling requirements is 99-22. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. 

 
We also have the following comments about your labels: 
  • The allergen “Contains” statements for both your Villagos Artisan Manchego Cheese and Villagos Manchego Cheese products declare milk as an allergen. Under FALCPA, only cow’s milk is considered a major food allergen. These products are made from sheep’s milk, which is not a major food allergen.
  • The Villagos Artisan Manchego Cheese and Villagos Machego Cheese products do not meet the net quantity of contents requirements under 21 CFR 101.105. Specifically, the regulation does not provide for the use of the word “minimum” followed by the net quantity statement.
We request that you respond to this office in writing, within 15 working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within 15 working days, your response should state the reason for the delay and the time within which corrections will be completed.
 
You should direct your written reply to: Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions regarding this letter you may contact Ms. Young via email at dehlia.young@fda.hhs.gov.
 
Sincerely,
/S/                                                           
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition

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