Sds De Mexico Sa De Cv

⚠️ Moderate Risk

FEI: 3000368601 • Mexicali, B C • MEXICO

FEI

FEI Number

3000368601

📍

Location

Mexicali, B C

🇲🇽

Country

MEXICO

🏢

Address

Circuito Sur No 31 Pque Ind Nelson, , Mexicali, B C, Mexico

Moderate Risk

FDA Import Risk Assessment

43.2

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

12/12/2011

Latest Refusal

6/23/2010

Earliest Refusal

Score Breakdown

Violation Severity

46.2×40%

Refusal Volume

49.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

11817×

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).

3414×

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).

Refusal History

Date	Product	Violations	Division
12/12/2011	76EJFBRACKET, METAL, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76DYWBRACKET, PLASTIC, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76JEXPLIER, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76JEXPLIER, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76DZNMATRIX, DENTAL	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76EJFBRACKET, METAL, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76DZNMATRIX, DENTAL	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76JEXPLIER, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76JEXPLIER, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76ECQALIGNER, BRACKET, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76DZNMATRIX, DENTAL	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76JEXPLIER, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
12/12/2011	76JEXPLIER, ORTHODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
9/23/2010	76ECIBAND, ELASTIC, ORTHODONTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
9/23/2010	76ECIBAND, ELASTIC, ORTHODONTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
9/23/2010	76DZBHEADGEAR, EXTRAORAL, ORTHODONTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
9/23/2010	76EJFBRACKET, METAL, ORTHODONTIC	118NOT LISTED 341REGISTERED	Los Angeles District Office (LOS-DO)
6/23/2010	76ECOSPRING, ORTHODONTIC	118NOT LISTED	Los Angeles District Office (LOS-DO)
6/23/2010	76ECOSPRING, ORTHODONTIC	118NOT LISTED	Los Angeles District Office (LOS-DO)
6/23/2010	76DZNMATRIX, DENTAL	118NOT LISTED	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sds De Mexico Sa De Cv's FDA import refusal history?

Sds De Mexico Sa De Cv (FEI: 3000368601) has 20 FDA import refusal record(s) in our database, spanning from 6/23/2010 to 12/12/2011.

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. Sds De Mexico Sa De Cv's FEI number is 3000368601.

What types of violations has Sds De Mexico Sa De Cv received?

Sds De Mexico Sa De Cv has been cited for 2 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 Sds De Mexico Sa De Cv come from?

All FDA import refusal data for Sds De Mexico 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.