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WARNING LETTER

Salazones Garre, S.L.


Recipient:
Salazones Garre, 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 6, 2014

WARNING LETTER 
 
 
VIA EXPRESS DELIVERY
 
Ms. Ana Maria Garre Garcia
Chief Executive Officer of Administration
Salazones Garre, S.L.
Avda. Artero Guirao, 254
San Pedro Del Pinatar, 30740
Spain
 
 Re: 441332
 
Dear Ms. Ana Maria Garre Garcia:
 
The United States Food and Drug Administration (FDA) inspected your facility, Salazones Garre, S.L., located in San Pedro Del Pinatar, Spain, on May 5, 2014 and May 6, 2014. The inspection was conducted to determine compliance with the Federal, Food, Drug, and Cosmetic Act (the Act) and regulations that apply to the food that you ship to the United States. Based on our review, we have concluded that your Garre Salazones y Ahymados Mojama Extra Loins Air Dried Yellowfin Tuna product is 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 Garre Salazones y Ahymados Mojama Extra Loins Air Dried Yellowfin Tuna product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not correctly declared on the product label. For example:
 
  • The product label fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure as required by 21 CFR 101.9(b)(7) and 101.9(d)(3)(i). The product label declares a serving size of 100g; however, the appropriate RACC for dried fish is 30g (21 CFR 101.12). Therefore, all nutrient amounts are incorrectly declared.
  • The product label fails to declare the number of servings per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(ii).
  • The statement of calories on the product label is expressed in terms of kcal, which is not in accordance with 21 CFR 101.9(c)(1).
  • The product label fails to declare the following required nutrients, as required by 21 CFR 101.9(c): 
o   Calories from fat; 21 CFR 101.9(c)(1)(ii).
o   Saturated fat; 21 CFR 101.9(c)(2)(i).
o   Trans-fat; 21 CFR 101.9(c)(2)(ii).
o   Cholesterol; 21 CFR 101.9(c)(3).
o   Sodium; 21 CFR 101.9(c)(4).
o   Total carbohydrates; 21 CFR 101.9(c)(6).
o   Dietary fiber; 21 CFR 101.9(c)(6)(i).
o   Sugars; 21 CFR 101.9(c)(6)(ii).
 
  • The product label fails to declare percent daily values as required by 21 CFR 101.9(d)(6).
  • The product label bears the claim “Alto Contenido En Protenias” which translates to “High in protein content”; however, the label fails to provide the percent daily value of protein as required by 21 CFR 101.9(c)(7)(i).
 
We also note that, in accordance with 21 CFR 101.9, nutrient content claims and Omega 3-6 statements are not permitted within the Nutrition Facts panel.
 
2.    Your Garre Salazones y Ahymados Mojama Extra Loins Air Dried Yellowfin Tuna product is also misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. § 343(f)] because it contains information in two languages, English and Spanish, but does not repeat all the required label information in both languages as required by 21 CFR 101.15(c)(2). For example, the Nutrition Facts information is only declared in Spanish.
 
3.    Your Garre Salazones y Ahymados Mojama Extra Loins Air Dried Yellowfin Tuna product is also misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the product label fails to provide an accurate statement of the quantity of contents in in terms of weight, measure, or numerical count in U.S. customary system of ounces, pounds, or fluid ounces. The net weight is only declared in metric units.
 
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 tuna product under Section 801(a) of the Act [21 U.S.C. § 381(a)], including placing it 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 food labeling requirements is 99-20. 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 request that you notify 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 and documentation of changes, including copies of new labels. If you cannot complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
 
We note that, on May 15, 2014, you responded to the FDA-483, Inspectional Observations, issued at the conclusion of the inspection at your firm. Your response appears to be adequate and we have no further comments or questions related to those items.
 
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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