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B.E.O.S. Gmbh

⚠️ Moderate Risk

FEI: 3012113135 • Schlusselfeld, Bavaria • GERMANY

FEI

FEI Number

3012113135

📍

Location

Schlusselfeld, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Thungbach 3, , Schlusselfeld, Bavaria, Germany

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
2
Unique Violations
5/10/2016
Latest Refusal
5/10/2016
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
5/10/2016
89JFBTABLE, PHYSICAL THERAPY, MULTI FUNCTION
3280FRNMFGREG
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is B.E.O.S. Gmbh's FDA import refusal history?

B.E.O.S. Gmbh (FEI: 3012113135) has 1 FDA import refusal record(s) in our database, spanning from 5/10/2016 to 5/10/2016.

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. B.E.O.S. Gmbh's FEI number is 3012113135.

What types of violations has B.E.O.S. Gmbh received?

B.E.O.S. 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 B.E.O.S. Gmbh come from?

All FDA import refusal data for B.E.O.S. 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.