Dr. Oetker Polska Sp. z o. o.
⚠️ Moderate Risk
FEI: 3004675587 • Gdansk, Pomorskie • POLAND
FEI Number
3004675587
Location
Gdansk, Pomorskie
Country
POLANDAddress
Ul. Arenda Dickmana 14/15, , Gdansk, Pomorskie, Poland
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
SULFITELBL
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/30/2016 | 35AGT99GELATIN, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/30/2016 | 35AGT99GELATIN, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/30/2016 | 35AGT99GELATIN, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/30/2016 | 35AGT99GELATIN, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/4/2010 | 03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING | 473LABELING | New York District Office (NYK-DO) |
| 6/4/2010 | 03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING | 324NO ENGLISH | New York District Office (NYK-DO) |
| 4/29/2008 | 35DDT99PUDDING (PIE FILLING) MIX, N.E.C. (NOT CUSTARD) | Chicago District Office (CHI-DO) | |
| 4/29/2008 | 35ADT01GELATIN, FLAVORED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Dr. Oetker Polska Sp. z o. o.'s FDA import refusal history?
Dr. Oetker Polska Sp. z o. o. (FEI: 3004675587) has 8 FDA import refusal record(s) in our database, spanning from 4/29/2008 to 6/30/2016.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Dr. Oetker Polska Sp. z o. o.'s FEI number is 3004675587.
What types of violations has Dr. Oetker Polska Sp. z o. o. received?
Dr. Oetker Polska Sp. z o. o. has been cited for 9 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Dr. Oetker Polska Sp. z o. o. come from?
All FDA import refusal data for Dr. Oetker Polska Sp. z o. o. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.