Z.PC Unitop-Optima S.A.
⚠️ Moderate Risk
FEI: 3004297653 • Lodz, Lodzkie • POLAND
FEI Number
3004297653
Location
Lodz, Lodzkie
Country
POLANDAddress
Ul. Andrzeja Struga 61, , Lodz, Lodzkie, 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
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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.
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).
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2021 | 23KGT02SESAME SEED (EDIBLE SEED) | Division of Northern Border Imports (DNBI) | |
| 12/8/2015 | 33EDT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Chicago District Office (CHI-DO) | |
| 12/8/2015 | 33EDT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Chicago District Office (CHI-DO) | |
| 11/22/2011 | 33EFT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 218LIST INGRE | New York District Office (NYK-DO) |
| 7/22/2011 | 33EFT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Z.PC Unitop-Optima S.A.'s FDA import refusal history?
Z.PC Unitop-Optima S.A. (FEI: 3004297653) has 5 FDA import refusal record(s) in our database, spanning from 7/22/2011 to 12/1/2021.
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. Z.PC Unitop-Optima S.A.'s FEI number is 3004297653.
What types of violations has Z.PC Unitop-Optima S.A. received?
Z.PC Unitop-Optima S.A. 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 Z.PC Unitop-Optima S.A. come from?
All FDA import refusal data for Z.PC Unitop-Optima 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.