HECHO EN MEXICO POR MERCK SA
⚠️ High Risk
FEI: 3030453093 • Guatemala • GUATEMALA
FEI Number
3030453093
Location
Guatemala
Country
GUATEMALAAddress
Calle 5 No 7 Fracc Indu, , 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2025 | 54AGK02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HECHO EN MEXICO POR MERCK SA's FDA import refusal history?
HECHO EN MEXICO POR MERCK SA (FEI: 3030453093) has 1 FDA import refusal record(s) in our database, spanning from 12/9/2025 to 12/9/2025.
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. HECHO EN MEXICO POR MERCK SA's FEI number is 3030453093.
What types of violations has HECHO EN MEXICO POR MERCK SA received?
HECHO EN MEXICO POR MERCK SA 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 HECHO EN MEXICO POR MERCK SA come from?
All FDA import refusal data for HECHO EN MEXICO POR MERCK 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.