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RUBIO DE B.C., S.A. DE C.V.

✅ Low Risk

FEI: 3004723973 • Mexicali, Baja California • MEXICO

FEI

FEI Number

3004723973

📍

Location

Mexicali, Baja California

🇲🇽

Country

MEXICO
🏢

Address

Carretera A San Luis Km. 7.5 S/N, Mexicali, Mexicali, Baja California, Mexico

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
3/10/2009
Latest Refusal
3/10/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

1181×

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).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
3/10/2009
63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
483DRUG NAME
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is RUBIO DE B.C., S.A. DE C.V.'s FDA import refusal history?

RUBIO DE B.C., S.A. DE C.V. (FEI: 3004723973) has 1 FDA import refusal record(s) in our database, spanning from 3/10/2009 to 3/10/2009.

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. RUBIO DE B.C., S.A. DE C.V.'s FEI number is 3004723973.

What types of violations has RUBIO DE B.C., S.A. DE C.V. received?

RUBIO DE B.C., S.A. DE C.V. 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 RUBIO DE B.C., S.A. DE C.V. come from?

All FDA import refusal data for RUBIO DE B.C., S.A. DE C.V. 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.