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GSK

⚠️ Moderate Risk

FEI: 3012908564 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3012908564

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Dr Annie Besant Road, Worli, Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

45.0
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
6/30/2021
Latest Refusal
4/20/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
12.5×10%
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

754×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
6/30/2021
61HCY14DAPSONE (ANTI-BACTERIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/20/2019
56BDK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/27/2018
66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/20/2018
64LDY07BETAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GSK's FDA import refusal history?

GSK (FEI: 3012908564) has 4 FDA import refusal record(s) in our database, spanning from 4/20/2018 to 6/30/2021.

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. GSK's FEI number is 3012908564.

What types of violations has GSK received?

GSK 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 GSK come from?

All FDA import refusal data for GSK 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.