MUNDO EXPRESS
⚠️ High Risk
FEI: 3016591954 • Morelia, Michoacan de Ocampo • MEXICO
FEI Number
3016591954
Location
Morelia, Michoacan de Ocampo
Country
MEXICOAddress
Privada Primer Privada De J. J. Tablada 308 L, Fracc. Las Bugambilias, Morelia, Morelia, Michoacan de Ocampo, 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 |
|---|---|---|---|
| 4/12/2023 | 64XAY06SALICYLIC ACID (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2023 | 61NCS78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 66JAY03LIOTRIX (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 61MAY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 61NAY66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 62CAY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 66FAY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 61PAY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 61XAY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 61HAY99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 61WAY99A-FUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 60LAY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 63BAY99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 56YAY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MUNDO EXPRESS's FDA import refusal history?
MUNDO EXPRESS (FEI: 3016591954) has 16 FDA import refusal record(s) in our database, spanning from 3/27/2023 to 4/12/2023.
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. MUNDO EXPRESS's FEI number is 3016591954.
What types of violations has MUNDO EXPRESS received?
MUNDO EXPRESS 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 MUNDO EXPRESS come from?
All FDA import refusal data for MUNDO EXPRESS 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.