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WARNING LETTER

NP Foods Ltd., Starburadze Production Facility


Recipient:
NP Foods Ltd., Starburadze Production Facility


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 

 DEC 23, 2014

WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Ms. Ieva Johnsson, Export Sales Director
NP Foods Ltd., Corporate Office
Miera Iela 22
Riga, Latvia 1001
 
Re: 444399
 
Dear Ms. Ieva Johnsson:
 
The United States Food and Drug Administration (FDA) inspected your facility, Agrovillaserra S.L. located in Castilla de la Mancha, Spain on July 17, 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 Laima Classic Wafer Cake With Crumbled Hazelnuts (8.82 oz.), Laima Classic Wafer Cake With Crumbled Hazelnuts (17.64 oz.), and Laima Selga Classic Biscuit 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 Laima Classic Wafer Cake With Crumbled Hazelnuts (8.82 oz.), Laima Classic Wafer Cake With Crumbled Hazelnuts (17.64 oz.), and Laima Selga Classic Biscuit products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Label) is not in a correct format as required by 21 CFR 101.9. For example:
  • The Laima Selga Classic Biscuit 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 Laima Selga Classic Biscuit product label is expressed as energy and in terms of kilocalories and kilojoules.  While the energy content can be declared, it should be declared parenthetically following the statement of caloric content in accordance with 21 CFR 101.9(c)(1).
  • The Laima Selga Classic Biscuit product label fails to declare calories from fat as required by 21 CFR 101.9(c)(1)(ii).
  • The Laima Classic Wafer Cake With Crumbled Hazelnuts (8.82 oz.), Laima Classic Wafer Cake With Crumbled Hazelnuts (17.64 oz.), and Laima Selga Classic Biscuit product labels fail to declare Trans-fat as required by 21 CFR 101.9(c)(2)(ii).
  • The Laima Selga Classic Biscuit product label fails to declare cholesterol as required by 21 CFR 101.9(c)(3).
  • The Laima Selga Classic Biscuit product label fails to declare Vitamin A, Vitamin C, Calcium, and Iron as required by 21 CFR 101.9(d)(8).
  • The Laima Selga Classic Biscuit product label fails to declare dietary fiber as required by 21 CFR 101.9(c)(6)(i).
 
2.    Your Laima Selga Classic Biscuit product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food. For example, the product label fails to declare a statement of identity of the food in English on the principal display panel as required by 21 CFR 101.3.
 
3.    Your Laima Classic Wafer Cake With Crumbled Hazelnuts (8.82 oz.), Laima Classic Wafer Cake With Crumbled Hazelnuts (17.64 oz.), and Laima Selga Classic Biscuit products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are 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:
  • The product labels declare “vegetable oil” and “partly [sic] hydrogenated vegetable oil” as ingredients; however, they fail to list each individual fat or oil ingredient as required by 21 CFR 101.4(b)(14).
  • The Laima Selga Classic Biscuit product label declares “natrium bicarbonate” in the ingredient statement; however, “natrium bicarbonate” is the common or usual name of this ingredient. If this ingredient is actually “sodium bicarbonate,” it must be labeled as such.
  • The Laima Selga Classic Biscuit product label declares “condensed milk with sugar” in the ingredient statement; however, “condensed milk” is the common or usual name of the ingredient. If this ingredient is actually “sweetened condensed milk;” it must be labeled as such in accordance with 21 CFR 131.120.
 
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 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 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 also have the following comments about your labels: 
  • FDA does not consider the bottom of the package to be an appropriate location for mandatory labeling statements. Mandatory labeling statements should be displayed on a portion of the package that is likely to be seen by the consumer. Additionally, all mandatory labeling statements must be in all languages represented on the label.
  • The required label statements must be prominently and conspicuously placed in accordance with 21 CFR 101.15(a)(6) to include smallness or style of type in which such word, statement, or information appears, insufficient background contrast…or crowding with other written, printed or graphic matter.
 
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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