Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A.
⚠️ Moderate Risk
FEI: 3003237541 • Brzeg, Opolskie • POLAND
FEI Number
3003237541
Location
Brzeg, Opolskie
Country
POLANDAddress
Ul. Starobrzeska 7, , Brzeg, Opolskie, 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
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).
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.
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.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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)).
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/26/2021 | 33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | Division of Northern Border Imports (DNBI) | |
| 1/22/2021 | 33YDT99CANDY WITHOUT CHOCOLATE N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/21/2017 | 33YDT99CANDY WITHOUT CHOCOLATE N.E.C. | 11UNSAFE COL | Division of Northern Border Imports (DNBI) |
| 9/6/2013 | 33EFT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Chicago District Office (CHI-DO) | |
| 9/6/2013 | 33EFT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Chicago District Office (CHI-DO) | |
| 4/20/2012 | 3300CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE) | New York District Office (NYK-DO) | |
| 2/17/2012 | 34FDT07MIXED OR ASSORTED CHOCOLATE CANDIES (BARS, BOXES, LOOSE FORM), WITHOUT NUTS AND FRUIT | 482NUTRIT LBL | New York District Office (NYK-DO) |
| 3/2/2010 | 33EFT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 324NO ENGLISH | New York District Office (NYK-DO) |
| 2/9/2010 | 33YDT99CANDY WITHOUT CHOCOLATE N.E.C. | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 1/12/2009 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 1/12/2009 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 1/12/2009 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 1/31/2008 | 33CFT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 8/23/2006 | 33YDT99CANDY WITHOUT CHOCOLATE N.E.C. | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 6/9/2006 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | New York District Office (NYK-DO) |
| 5/24/2006 | 33LFT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Seattle District Office (SEA-DO) |
| 7/25/2005 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 218LIST INGRE | New York District Office (NYK-DO) |
| 6/30/2005 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | New York District Office (NYK-DO) | |
| 5/12/2005 | 33YDT99CANDY WITHOUT CHOCOLATE N.E.C. | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 1/14/2005 | 33YGT99CANDY WITHOUT CHOCOLATE N.E.C. | 9SALMONELLA | Chicago District Office (CHI-DO) |
| 6/18/2004 | 33EFT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Chicago District Office (CHI-DO) |
| 4/15/2004 | 34GGT07MIXED OR ASSORTED CHOCOLATE CANDIES (BARS, BOXES, LOOSE FORM), WITH NUTS AND FRUIT | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A.'s FDA import refusal history?
Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A. (FEI: 3003237541) has 22 FDA import refusal record(s) in our database, spanning from 4/15/2004 to 11/26/2021.
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. Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A.'s FEI number is 3003237541.
What types of violations has Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A. received?
Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A. has been cited for 8 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 Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A. come from?
All FDA import refusal data for Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A. 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.