ARSENAL PL Sp. Z o. o
⚠️ Moderate Risk
FEI: 3003385761 • Bialystok, Podlaskie • POLAND
FEI Number
3003385761
Location
Bialystok, Podlaskie
Country
POLANDAddress
Ul. Przedzalniana 6H, , Bialystok, Podlaskie, 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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
IMBED OBJT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a confectionary that has partially or completely imbedded therein any nonnutritive object.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2017 | 34KYY04CHOCOLATE BARS | Division of Northeast Imports (DNEI) | |
| 8/10/2017 | 34KYY04CHOCOLATE BARS | 299IMBED OBJT | Division of Northeast Imports (DNEI) |
| 7/17/2013 | 54BCA01CALCIUM (MINERAL) | 482NUTRIT LBL | Division of Northeast Imports (DNEI) |
| 7/17/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 7/17/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 7/17/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 7/17/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 7/17/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 198COLOR LBLG | Division of Northeast Imports (DNEI) |
| 3/1/2012 | 40EDT40FRUIT FLAVORED DRINK | Chicago District Office (CHI-DO) | |
| 7/28/2009 | 33LFT12MIXED/ASSORTED SOFT CANDY WITHOUT NUTS, FRUIT OR CHOCOLATE) | 11UNSAFE COL | New York District Office (NYK-DO) |
| 1/2/2008 | 34FFT01CHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT | 299IMBED OBJT | New York District Office (NYK-DO) |
| 8/10/2004 | 03HFT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | 11UNSAFE COL | New York District Office (NYK-DO) |
| 8/10/2004 | 03HFT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | 11UNSAFE COL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ARSENAL PL Sp. Z o. o's FDA import refusal history?
ARSENAL PL Sp. Z o. o (FEI: 3003385761) has 13 FDA import refusal record(s) in our database, spanning from 8/10/2004 to 10/3/2017.
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. ARSENAL PL Sp. Z o. o's FEI number is 3003385761.
What types of violations has ARSENAL PL Sp. Z o. o received?
ARSENAL PL Sp. Z o. o has been cited for 6 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 ARSENAL PL Sp. Z o. o come from?
All FDA import refusal data for ARSENAL PL 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.