Syntex Sa De
⚠️ Moderate Risk
FEI: 3005426802 • Estado • MEXICO
FEI Number
3005426802
Location
Estado
Country
MEXICOAddress
Via I Fabela Norte 1536, , Estado, , Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 10/12/2017 | 65PDY03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 65ADY04MEMANTINE HCI | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 66FCA99SUPPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Syntex Sa De's FDA import refusal history?
Syntex Sa De (FEI: 3005426802) has 4 FDA import refusal record(s) in our database, spanning from 12/27/2011 to 10/12/2017.
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. Syntex Sa De's FEI number is 3005426802.
What types of violations has Syntex Sa De received?
Syntex Sa De 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 Syntex Sa De come from?
All FDA import refusal data for Syntex Sa De 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.