Glaxo Smith Kline
⚠️ Moderate Risk
FEI: 3009212109 • Andhra Pradesh • INDIA
FEI Number
3009212109
Location
Andhra Pradesh
Country
INDIAAddress
Southern Drugs & Pharmaceutical Doodoor, , Andhra Pradesh, , India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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
Frequently Asked Questions
What is Glaxo Smith Kline's FDA import refusal history?
Glaxo Smith Kline (FEI: 3009212109) has 3 FDA import refusal record(s) in our database, spanning from 12/21/2011 to 12/21/2011.
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's FEI number is 3009212109.
What types of violations has Glaxo Smith Kline received?
Glaxo Smith Kline 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 come from?
All FDA import refusal data for Glaxo Smith Kline 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.