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GLAXOSMITHKLINE CONSUMER HEALTHCARE SP ZOO

✅ Low Risk

FEI: 3014364110 • Warszawa • POLAND

FEI

FEI Number

3014364110

📍

Location

Warszawa

🇵🇱

Country

POLAND
🏢

Address

Ul. Rzymowskiego 53, , Warszawa, , Poland

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
5/19/2020
Latest Refusal
5/19/2020
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
5/19/2020
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
471CSTIC LBLG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is GLAXOSMITHKLINE CONSUMER HEALTHCARE SP ZOO's FDA import refusal history?

GLAXOSMITHKLINE CONSUMER HEALTHCARE SP ZOO (FEI: 3014364110) has 1 FDA import refusal record(s) in our database, spanning from 5/19/2020 to 5/19/2020.

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. GLAXOSMITHKLINE CONSUMER HEALTHCARE SP ZOO's FEI number is 3014364110.

What types of violations has GLAXOSMITHKLINE CONSUMER HEALTHCARE SP ZOO received?

GLAXOSMITHKLINE CONSUMER HEALTHCARE SP ZOO has been cited for 1 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 GLAXOSMITHKLINE CONSUMER HEALTHCARE SP ZOO come from?

All FDA import refusal data for GLAXOSMITHKLINE CONSUMER HEALTHCARE SP ZOO 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.