Glasxosmithkline Pharmaceuticals
⚠️ High Risk
FEI: 3004378928 • Nashik, Maharashtra • INDIA
FEI Number
3004378928
Location
Nashik, Maharashtra
Country
INDIAAddress
Ambad - Pathardi Block, A - 10 Midc Ambad Nashik Road, Nashik, Maharashtra, 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 |
|---|---|---|---|
| 10/16/2024 | 63BCO25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2021 | 65NDY76THYROXINE I 125 (RADIOACTIVE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2020 | 66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/9/2020 | 65NDY76THYROXINE I 125 (RADIOACTIVE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2008 | 64LDO08BETAMETHASONE VALERATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 11/5/2008 | 64LDO08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/19/2004 | 63BDY25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/19/2004 | 63BDY25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Glasxosmithkline Pharmaceuticals's FDA import refusal history?
Glasxosmithkline Pharmaceuticals (FEI: 3004378928) has 8 FDA import refusal record(s) in our database, spanning from 10/19/2004 to 10/16/2024.
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. Glasxosmithkline Pharmaceuticals's FEI number is 3004378928.
What types of violations has Glasxosmithkline Pharmaceuticals received?
Glasxosmithkline Pharmaceuticals 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 Glasxosmithkline Pharmaceuticals come from?
All FDA import refusal data for Glasxosmithkline Pharmaceuticals 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.