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SEDECAL SA

⚠️ Moderate Risk

FEI: 3002495042 • Algete, Madrid • SPAIN

FEI

FEI Number

3002495042

📍

Location

Algete, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Pelaya, 9 Pol., Pol. Ind. Rio De Janeiro, Algete, Madrid, Spain

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
1/22/2007
Latest Refusal
1/9/2007
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

472×

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
1/22/2007
94RCBX-RAY CONTROLS - RADIOGRAPHIC, MEDICAL DIAGNOSTIC X-RAY EQUIPMENT
47NON STD
Division of Southeast Imports (DSEI)
1/9/2007
94RCBX-RAY CONTROLS - RADIOGRAPHIC, MEDICAL DIAGNOSTIC X-RAY EQUIPMENT
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SEDECAL SA's FDA import refusal history?

SEDECAL SA (FEI: 3002495042) has 2 FDA import refusal record(s) in our database, spanning from 1/9/2007 to 1/22/2007.

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. SEDECAL SA's FEI number is 3002495042.

What types of violations has SEDECAL SA received?

SEDECAL SA 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 SEDECAL SA come from?

All FDA import refusal data for SEDECAL SA 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.