GlaxoSmithKline
⚠️ Moderate Risk
FEI: 3004688211 • Philadelphia, PA • UNITED STATES
FEI Number
3004688211
Location
Philadelphia, PA
Country
UNITED STATESAddress
1 Franklin Sq, , Philadelphia, PA, United States
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
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2014 | 61TDB26ONDANSETRON (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/11/2012 | 62FCO52CALCIUM MUPIROCIN (ANTI-INFECTIVE, TOPICAL) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 60LAB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/1/2004 | 66JCF01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is GlaxoSmithKline's FDA import refusal history?
GlaxoSmithKline (FEI: 3004688211) has 4 FDA import refusal record(s) in our database, spanning from 11/1/2004 to 2/21/2014.
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's FEI number is 3004688211.
What types of violations has GlaxoSmithKline received?
GlaxoSmithKline 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 come from?
All FDA import refusal data for GlaxoSmithKline 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.