Silimed Mexico
⚠️ Moderate Risk
FEI: 3006341095 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3006341095
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Uxmal 214, Col. Narvarte Poniente, Benito Juarez, Ciudad De Mexico, Ciudad de Mexico, 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
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/12/2007 | 87MOOORTHOPEDIC IMPLANT MATERIAL | 2380NO PMA/PDP | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Silimed Mexico's FDA import refusal history?
Silimed Mexico (FEI: 3006341095) has 1 FDA import refusal record(s) in our database, spanning from 7/12/2007 to 7/12/2007.
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. Silimed Mexico's FEI number is 3006341095.
What types of violations has Silimed Mexico received?
Silimed Mexico 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 Silimed Mexico come from?
All FDA import refusal data for Silimed Mexico 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.