HECHO EN MEXICO POR LABORATORIOS
⚠️ High Risk
FEI: 3029819152 • Puebla • MEXICO
FEI Number
3029819152
Location
Puebla
Country
MEXICOAddress
23 Poniente 23-A, Col Vo, Puebla, , Mexico
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 |
|---|---|---|---|
| 12/7/2023 | 62GDB42INDOMETHACIN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HECHO EN MEXICO POR LABORATORIOS's FDA import refusal history?
HECHO EN MEXICO POR LABORATORIOS (FEI: 3029819152) has 1 FDA import refusal record(s) in our database, spanning from 12/7/2023 to 12/7/2023.
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 LABORATORIOS's FEI number is 3029819152.
What types of violations has HECHO EN MEXICO POR LABORATORIOS received?
HECHO EN MEXICO POR LABORATORIOS 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 LABORATORIOS come from?
All FDA import refusal data for HECHO EN MEXICO POR LABORATORIOS 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.