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Przedsiebiorstwo Wyrobow Cukierniczych Odra S.A.

⚠️ Moderate Risk

FEI: 3003237541 • Brzeg, Opolskie • POLAND

FEI

FEI Number

3003237541

📍

Location

Brzeg, Opolskie

🇵🇱

Country

POLAND
🏢

Address

Ul. Starobrzeska 7, , Brzeg, Opolskie, Poland

Moderate Risk

FDA Import Risk Assessment

47.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

22
Total Refusals
8
Unique Violations
11/26/2021
Latest Refusal
4/15/2004
Earliest Refusal

Score Breakdown

Violation Severity
68.3×40%
Refusal Volume
50.4×30%
Recency
17.1×20%
Frequency
12.5×10%
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

1115×

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).

4824×

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.

2184×

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.

92×

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.

2742×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

3241×

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)).

3211×

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

DateProductViolationsDivision
11/26/2021
33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
Division of Northern Border Imports (DNBI)
1/22/2021
33YDT99CANDY WITHOUT CHOCOLATE N.E.C.
482NUTRIT LBL
9SALMONELLA
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)
11UNSAFE COL
274COLOR LBLG
Chicago District Office (CHI-DO)
9/6/2013
33EFT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Chicago District Office (CHI-DO)
4/20/2012
3300CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE)
473LABELING
482NUTRIT LBL
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)
11UNSAFE COL
218LIST INGRE
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
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
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.