laboratorio Qualipharm
⚠️ High Risk
FEI: 3031342835 • de Guatemala • GUATEMALA
FEI Number
3031342835
Location
de Guatemala
Country
GUATEMALAAddress
4 Avenida 19-33, Cdad., , de Guatemala, , 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
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).
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 laboratorio Qualipharm's FDA import refusal history?
laboratorio Qualipharm (FEI: 3031342835) has 1 FDA import refusal record(s) in our database, spanning from 12/17/2025 to 12/17/2025.
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. laboratorio Qualipharm's FEI number is 3031342835.
What types of violations has laboratorio Qualipharm received?
laboratorio Qualipharm 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 laboratorio Qualipharm come from?
All FDA import refusal data for laboratorio Qualipharm 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.