Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
MAY 12 2015
VIA EXPRESS DELIVERY
Mr. Mieczyslaw Sekula, Director of Production
Chlodnia Grudziadz Sp. Z o.o.
ul. Gen. Jozefa Kustronia 13
NIP: 876-233-01-25, Region 340162937
Grudziadz, 86-300 Poland
Dear Mr. Mieczyslaw Sekula:
The United States Food and Drug Administration (FDA) inspected your facility, Chlodnia Grudziadz Sp. Z o.o., located in Grudziadz, Poland, on November 6-7,2014. 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 Krolewski bukiet warzyw, Marchewka z grosckiem, and Zupa Krolewska ze Szpinakiem 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 Zupa Krolewska ze Szpinakiem product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare the presence of major food allergens present in the products, namely milk, as required by section 403(w)(1) of the Act. Specifically, your product contains the ingredient, cream, which you identified to our investigator as being of "dairy" origin. Further, cream is defined as being a product separated from milk; milk has a standard of identity stating that it is from cows [21 CFR 131.3(a) and 21 CFR 131.110(a), respectively]. Inasmuch as this product is cream derived from cow's milk, it must be declared in accordance with section 403(w) of the Act [21 U.S.C. § 343(w)].
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as "major food allergens" 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. A food is misbranded 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., "flour (wheat)"), except that 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 Krolewski bukiet warzyw, Marchewka z grosckiem, and Zupa Krolewska ze Szpinakiem products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in two languages, but does not repeat all the required information in the English language. As required by 21 CFR 101.15(c)(1), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in English. For example, on the principal display panel, the statement of identity is stated in Polish but not in English.
3. Your Krolewski bukiet warzyw, Marchewka z grosckiem, and Zupa Krolewska ze Szpinakiem products are misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. § 343(f)] because the Nutrition Facts panel is not formatted as required by 21 CFR 101.9. For example:
a. The Nutrition Facts panels for the Krolewski bukiet warzyw and Marchewka z grosckiem identify the serving size as 450 g (per your revised March 13, 2015 label) which is not in compliance with 21 CFR 101.9(b) and 21 CFR 101.12(b). These products are represented to be vegetables and the Reference Amount Customarily Consumed (RACC) for vegetables is 85 g.
b. The Nutrition Facts panel for the Zupa Krolewska ze Szpinakiem identify the serving size as 450 g (per your revised March 13, 2015 label), which is not in compliance with 21 CFR 101.9(b) and 21 CFR 101.12(b). This product is represented to be soup and the RACC for soup is 245 g.
c. The Nutrition Facts panels for Krolewski bukiet warzyw, Marchewka z grosckiem, and Zupa Krolewska ze Szpinakiem
• Fail to list the number of servings per container based upon the proper RACC and in the correct format as required by 21 CFR 101.9(d)(3)(ii);
• You have identified a "% Daily Value" for Sugar and no Daily Reference Value (DRV) has been established for sugar [21 CFR 101.9(c)(9)]; and
• The percentage of the Daily Reference Value for the declared nutrients are not based on the serving size as required by 21 CFR 101.9(c)(9).
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 vegetable 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 while the Import Alerts that convey information specific to foreign firms that are not in compliance with nutritional labeling and basic labeling requirements are 99-20 and 99-39, respectively. You may view these alerts at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
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 ingredient statement in the Krolewski bukiet warzyw contains intervening material, "in varying proportions," which is not permissible under 21 CFR 101.2(e).
• The ingredient statement for both the Krolewski bukiet warzyw and Marchewka z grosckiem states "May contain celeriac." If this statement is intended to be precautionary, it must not be used in lieu of good manufacturing practices.
• The ingredient statements in the label and labeling for the Zupa Krolewska ze Szpinakiem product are inconsistent, for example "seasoning" versus "spices" and "celeriac" versus "celery." You must declare the ingredients used in the product consistent with the requirements under 21 CFR 101.4. Further, if you are using "seasonings" rather than "spices," you must list the sub-ingredients of the seasoning.
• The Zupa Krolewska ze Szpinakiem in your information panel identifies the product as "Royal Soup - Vegetable Mix with Spinach in Cream Sauce." The picture on the principle display panel depicts the product as a soup but the information on the back panel describes it as both a soup and a sauce. We suggest that you clarify the name of the product under 21 CFR 101.3 and 102.5.
• The net quantity of contents statement on these products is located on the back of the package. Net quantity of content statements are to be located on the principle display panel in the lower 30% [21 CFR 101.105(f)] and be declared in avoirdupois pound and ounce [21 CFR 101.105(b)(1)].
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
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: Tyra Wisecup, 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. Wisecup via email at email@example.com.
William A. Correll, Jr
Office of Compliance
Center for Food Safety
and Applied Nutrition