INVERSIONES Y SERV
⚠️ High Risk
FEI: 3014184606 • Guadalajara • MEXICO
FEI Number
3014184606
Location
Guadalajara
Country
MEXICOAddress
Calle 8 1989, , Guadalajara, , 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 |
|---|---|---|---|
| 3/14/2019 | 61WCE46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2019 | 61PBY31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/29/2019 | 64GCE29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 61PCE26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 64BCE99DIURETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 61PCB11GLYBURIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is INVERSIONES Y SERV's FDA import refusal history?
INVERSIONES Y SERV (FEI: 3014184606) has 7 FDA import refusal record(s) in our database, spanning from 1/16/2019 to 3/14/2019.
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. INVERSIONES Y SERV's FEI number is 3014184606.
What types of violations has INVERSIONES Y SERV received?
INVERSIONES Y SERV 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 INVERSIONES Y SERV come from?
All FDA import refusal data for INVERSIONES Y SERV 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.