GLAXOSMITHKLINE PHARMACEUTICALSLTD
⚠️ High Risk
FEI: 3017610470 • Nasik • INDIA
FEI Number
3017610470
Location
Nasik
Country
INDIAAddress
A-10, M.I.D.C., Industrial Area, Pathardi Block, , Nasik, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/16/2024 | 64LDY03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 66JDB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/5/2011 | 56CCE73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2010 | 61HCA14DAPSONE (ANTI-BACTERIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2006 | 56YCE99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/23/2005 | 66JCY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/4/2005 | 63BAY25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/29/2004 | 64LDJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | San Francisco District Office (SAN-DO) | |
| 9/4/2002 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is GLAXOSMITHKLINE PHARMACEUTICALSLTD's FDA import refusal history?
GLAXOSMITHKLINE PHARMACEUTICALSLTD (FEI: 3017610470) has 12 FDA import refusal record(s) in our database, spanning from 9/4/2002 to 9/16/2024.
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 PHARMACEUTICALSLTD's FEI number is 3017610470.
What types of violations has GLAXOSMITHKLINE PHARMACEUTICALSLTD received?
GLAXOSMITHKLINE PHARMACEUTICALSLTD has been cited for 2 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 PHARMACEUTICALSLTD come from?
All FDA import refusal data for GLAXOSMITHKLINE PHARMACEUTICALSLTD 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.