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SAAB AB

⚠️ Moderate Risk

FEI: 3012836024 • GOTHENBURG • SWEDEN

FEI

FEI Number

3012836024

📍

Location

GOTHENBURG

🇸🇪

Country

SWEDEN
🏢

Address

SOLNUSGATAN 10, , GOTHENBURG, , Sweden

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/29/2016
Latest Refusal
11/29/2016
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
11/29/2016
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is SAAB AB's FDA import refusal history?

SAAB AB (FEI: 3012836024) has 1 FDA import refusal record(s) in our database, spanning from 11/29/2016 to 11/29/2016.

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. SAAB AB's FEI number is 3012836024.

What types of violations has SAAB AB received?

SAAB AB 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 SAAB AB come from?

All FDA import refusal data for SAAB AB 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.