ImportRefusal LogoImportRefusal

Opsytec Dr. Groebel Gmbh

⚠️ Moderate Risk

FEI: 3010387228 • Ettlingen, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3010387228

📍

Location

Ettlingen, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Goethestr. 17, , Ettlingen, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/15/2002
Latest Refusal
4/15/2002
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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.

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
4/15/2002
95U20ULTRAVIOLET PRODUCT (MISCELLANEOUS) FOR NON-MEDICAL USE
47NON STD
476NO REGISTR
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Opsytec Dr. Groebel Gmbh's FDA import refusal history?

Opsytec Dr. Groebel Gmbh (FEI: 3010387228) has 1 FDA import refusal record(s) in our database, spanning from 4/15/2002 to 4/15/2002.

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. Opsytec Dr. Groebel Gmbh's FEI number is 3010387228.

What types of violations has Opsytec Dr. Groebel Gmbh received?

Opsytec Dr. Groebel Gmbh 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 Opsytec Dr. Groebel Gmbh come from?

All FDA import refusal data for Opsytec Dr. Groebel Gmbh 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.