Glaxo Smith Pharma Ltd
⚠️ High Risk
FEI: 3005850679 • Mumbai, Maharashtra • INDIA
FEI Number
3005850679
Location
Mumbai, Maharashtra
Country
INDIAAddress
1000 Dr Annie Besant Road, , Mumbai, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2024 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2019 | 65NCA76THYROXINE I 125 (RADIOACTIVE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/14/2007 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Glaxo Smith Pharma Ltd's FDA import refusal history?
Glaxo Smith Pharma Ltd (FEI: 3005850679) has 3 FDA import refusal record(s) in our database, spanning from 5/14/2007 to 3/29/2024.
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. Glaxo Smith Pharma Ltd's FEI number is 3005850679.
What types of violations has Glaxo Smith Pharma Ltd received?
Glaxo Smith Pharma Ltd 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 Pharma Ltd come from?
All FDA import refusal data for Glaxo Smith Pharma Ltd 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.