Deposito Dental Villa De Cortez Sa De Cv
⚠️ Moderate Risk
FEI: 3003645796 • Mexico D.F. • MEXICO
FEI Number
3003645796
Location
Mexico D.F.
Country
MEXICOAddress
Calzada De Tlalpan No. 836, Col. Villa De, Mexico D.F., , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 3/27/2009 | 76NMEBUR, DIAMOND COATED, REPROCESSED | Southwest Import District Office (SWI-DO) | |
| 3/27/2009 | 76EMACEMENT, DENTAL | Southwest Import District Office (SWI-DO) | |
| 5/14/2002 | 60QDJ67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/14/2002 | 60QDJ56BENZOCAINE (ANESTHETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Deposito Dental Villa De Cortez Sa De Cv's FDA import refusal history?
Deposito Dental Villa De Cortez Sa De Cv (FEI: 3003645796) has 4 FDA import refusal record(s) in our database, spanning from 5/14/2002 to 3/27/2009.
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. Deposito Dental Villa De Cortez Sa De Cv's FEI number is 3003645796.
What types of violations has Deposito Dental Villa De Cortez Sa De Cv received?
Deposito Dental Villa De Cortez Sa De Cv has been cited for 3 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 Deposito Dental Villa De Cortez Sa De Cv come from?
All FDA import refusal data for Deposito Dental Villa De Cortez Sa De Cv 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.