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  5. Zdenka d.d - 11/14/2014
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WARNING LETTER

Zdenka d.d


Recipient:
Zdenka d.d


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 14, 2014
 

WARNING LETTER

VIA EXPRESS DELIVERY

Mr. Zeliko Gatjal, General Manager
Zdenka d.d
Trg Kralja Tomislava 15
Veliki Zdenci, Croatia
 

Re:441438
 

Dear Mr. Zeliko Gatjal:

The United States Food and Drug Administration (FDA) inspected your facility, Zdenka d.d located in Veliki Zdenci, Croatia on July 7, 2014 through July 8, 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 cheese products (Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore) 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 Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded within the meaning of Section 403(q) of the Act (21 U.S.C. § 343(q)] in that the nutrition information is not provided as specified under 21 CFR 101.9. For example:
 

• The Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore products serving size is not expressed as a "reference amount customarily consumed" (RACC) that is appropriate to the food as defined within 21 CFR 101.12.
 

• The Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore product labels fail to declare a serving size per container as required by 21 CFR 101.9(b)(8) and 101.9(d)(3)(i).
 

• The Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore product labels fail to declare trans-fat as required by 21 CFR 101.9(c)(2)(ii).
 

• The Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore product labels fail to declare calories from fat as required by 21 CPR 101.9(c)(1)(ii).
 

• The Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore product labels declare caloric content in Kcal or KJ which is not in accordance with 21 CPR 101.9(c)(l).
 

• The Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore product labels fail to declare cholesterol as required by 21 CPR 101.9(c)(3).
 

• The Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore product labels fail to declare Vitamin A, Vitamin C, Calcium, and iron as required by 21 CPR 101.9(d)(8).
 

• The Zdenka SPORT polutvrdi sir trapist bez kore product label fails to declare sugar as required by 21 CPR 101.9(c)(6)(ii).
 

• The Zdenka SPORT polutvrdi sir trapist bez kore product label fails to declare sodium as required by 21 CPR 101.9(c)(4).
 

• The Zdenka SPORT polutvrdi sir trapist bez kore product label fails to declare saturated fat as required by 21 CPR 101.9(c)(2)(i).
 

2.    Your Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded within the meaning of Section 403(f) ofthe Act [21 U.S.C. §343(f)] because they contain information in two languages but does not repeat all the required label information in both languages. For example, the Nutrition Facts and statement of identity information must be declared in both, the foreign language and English as required by 21 CPR 101.15(c)(2).

3.    Your Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore products are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because they fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CPR 101.105.

Additionally, we have reviewed you firm's response dated July 28, 2014, to the observations of noted concern listed on FDA-Form 483. Your response included a summary of corrective actions taken by your facility, revised record templates, calibration reports, and procedures for testing your bypass control valve. However, review of your response left continuing concern with the handling of the bird nests that were observed attached to an overhang covering where raw milk is unloaded from delivery trucks. Your response stated that your firm will hire a company to address this observation; however, we would like to see additional evidence to ensure that this issue has been resolved.

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 product 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_ialialist.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 ofthis letter. Your response should include the specific steps you have taken to correct the violations. If you cannot complete all ofthe corrections within 15 working days, 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