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Actos

⚠️ Moderate Risk

FEI: 3009091636 • Dusseldorf • GERMANY

FEI

FEI Number

3009091636

📍

Location

Dusseldorf

🇩🇪

Country

GERMANY
🏢

Address

Stadttor Dusseldorf D-40219, , Dusseldorf, , Germany

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/15/2011
Latest Refusal
9/15/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

473×

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
9/15/2011
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Detroit District Office (DET-DO)
9/15/2011
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Detroit District Office (DET-DO)
9/15/2011
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Actos's FDA import refusal history?

Actos (FEI: 3009091636) has 3 FDA import refusal record(s) in our database, spanning from 9/15/2011 to 9/15/2011.

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. Actos's FEI number is 3009091636.

What types of violations has Actos received?

Actos 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 Actos come from?

All FDA import refusal data for Actos 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.