GLAXOSMITHKLINE GUATEMALA SA
⚠️ High Risk
FEI: 3029056439 • Ciudad Vieja, Sacatepequez • GUATEMALA
FEI Number
3029056439
Location
Ciudad Vieja, Sacatepequez
Country
GUATEMALAAddress
Avenida 13 78 Zona 3ra, , Ciudad Vieja, Sacatepequez, Guatemala
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
Frequently Asked Questions
What is GLAXOSMITHKLINE GUATEMALA SA's FDA import refusal history?
GLAXOSMITHKLINE GUATEMALA SA (FEI: 3029056439) has 2 FDA import refusal record(s) in our database, spanning from 1/14/2025 to 12/5/2025.
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 GUATEMALA SA's FEI number is 3029056439.
What types of violations has GLAXOSMITHKLINE GUATEMALA SA received?
GLAXOSMITHKLINE GUATEMALA SA 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 GUATEMALA SA come from?
All FDA import refusal data for GLAXOSMITHKLINE GUATEMALA SA 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.