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Dr. Gerard Sp. z o.o.

⚠️ Moderate Risk

FEI: 3013157148 • Miedzyrzec Podlaski, Lubelskie • POLAND

FEI

FEI Number

3013157148

📍

Location

Miedzyrzec Podlaski, Lubelskie

🇵🇱

Country

POLAND
🏢

Address

Ul. Radzynska 9, , Miedzyrzec Podlaski, Lubelskie, Poland

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/24/2013
Latest Refusal
4/24/2013
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

111×

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).

3281×

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.

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
4/24/2013
03JGT09FRUIT/FRUIT FLAVORED FILLED/ICED COOKIES,BISCUITS AND WAFERS
11UNSAFE COL
328USUAL NAME
473LABELING
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Dr. Gerard Sp. z o.o.'s FDA import refusal history?

Dr. Gerard Sp. z o.o. (FEI: 3013157148) has 1 FDA import refusal record(s) in our database, spanning from 4/24/2013 to 4/24/2013.

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. Gerard Sp. z o.o.'s FEI number is 3013157148.

What types of violations has Dr. Gerard Sp. z o.o. received?

Dr. Gerard Sp. z o.o. has been cited for 3 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. Gerard Sp. z o.o. come from?

All FDA import refusal data for Dr. Gerard 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.