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F.P. Rubinstein Y Cia SRL

⚠️ Moderate Risk

FEI: 3003735408 • Cordoba, Cordoba • ARGENTINA

FEI

FEI Number

3003735408

📍

Location

Cordoba, Cordoba

🇦🇷

Country

ARGENTINA
🏢

Address

Calle David Luque 519, , Cordoba, Cordoba, Argentina

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/13/2012
Latest Refusal
11/13/2012
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
11/13/2012
89IMIDIATHERMY, ULTRASONIC, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
47NON STD
Florida District Office (FLA-DO)

Frequently Asked Questions

What is F.P. Rubinstein Y Cia SRL's FDA import refusal history?

F.P. Rubinstein Y Cia SRL (FEI: 3003735408) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2012 to 11/13/2012.

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. F.P. Rubinstein Y Cia SRL's FEI number is 3003735408.

What types of violations has F.P. Rubinstein Y Cia SRL received?

F.P. Rubinstein Y Cia SRL 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 F.P. Rubinstein Y Cia SRL come from?

All FDA import refusal data for F.P. Rubinstein Y Cia SRL 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.