GlaxoSmithKline Office of Affairs
⚠️ Moderate Risk
FEI: 1000394670 • Saint-Laurent, QC • CANADA
FEI Number
1000394670
Location
Saint-Laurent, QC
Country
CANADAAddress
Bureau Of Affairs - Quebec, 8455, Route Transcanadienne, Saint-Laurent, QC, Canada
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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
Frequently Asked Questions
What is GlaxoSmithKline Office of Affairs's FDA import refusal history?
GlaxoSmithKline Office of Affairs (FEI: 1000394670) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2003 to 10/16/2003.
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 Office of Affairs's FEI number is 1000394670.
What types of violations has GlaxoSmithKline Office of Affairs received?
GlaxoSmithKline Office of Affairs has been cited for 3 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 Office of Affairs come from?
All FDA import refusal data for GlaxoSmithKline Office of Affairs 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.