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Glaxo Smith Kline Consumer He

✅ Low Risk

FEI: 3007217724 • Mumbai • INDIA

FEI

FEI Number

3007217724

📍

Location

Mumbai

🇮🇳

Country

INDIA
🏢

Address

(N) Nabha-147 201 (Punjab)Jagajit Nagar, , Mumbai, , India

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/19/2010
Latest Refusal
8/19/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/19/2010
66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Glaxo Smith Kline Consumer He's FDA import refusal history?

Glaxo Smith Kline Consumer He (FEI: 3007217724) has 1 FDA import refusal record(s) in our database, spanning from 8/19/2010 to 8/19/2010.

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. Glaxo Smith Kline Consumer He's FEI number is 3007217724.

What types of violations has Glaxo Smith Kline Consumer He received?

Glaxo Smith Kline Consumer He 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 Glaxo Smith Kline Consumer He come from?

All FDA import refusal data for Glaxo Smith Kline Consumer He 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.