BEST MEDICAL GMBH

⚠️ Moderate Risk

FEI: 3008739375 • Emmingen-Liptingen, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3008739375

📍

Location

Emmingen-Liptingen, Baden-Wurttemberg

🇩🇪

Country

GERMANY

🏢

Address

Heudorfer Str. 32, , Emmingen-Liptingen, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

45.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/1/2023

Latest Refusal

11/13/2014

Earliest Refusal

Score Breakdown

Violation Severity

40.4×40%

Refusal Volume

59.3×30%

Recency

32.3×20%

Frequency

47.4×10%

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

Violation Summary

34139×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

11821×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

328021×

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.

Refusal History

Date	Product	Violations	Division
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	86HNNKNIFE, OPHTHALMIC	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79HTDFORCEPS	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79HTDFORCEPS	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79HTDFORCEPS	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	87HXKHOLDER, NEEDLE; ORTHOPEDIC	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	87HXKHOLDER, NEEDLE; ORTHOPEDIC	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	77KAEFORCEPS, ENT	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
2/1/2023	79LRWSCISSORS, GENERAL USE, SURGICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
11/13/2014	78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FGNRETRACTOR, NON-SELF-RETAINING	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	79HTRRASP	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FFPDILATOR, RECTAL	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FBMCANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	87HRRSCISSORS	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	87HRRSCISSORS	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	87HXKHOLDER, NEEDLE; ORTHOPEDIC	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FGNRETRACTOR, NON-SELF-RETAINING	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	79HTDFORCEPS	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	79HTDFORCEPS	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FGNRETRACTOR, NON-SELF-RETAINING	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)	341REGISTERED	New Orleans District Office (NOL-DO)
11/13/2014	78FGNRETRACTOR, NON-SELF-RETAINING	341REGISTERED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is BEST MEDICAL GMBH's FDA import refusal history?

BEST MEDICAL GMBH (FEI: 3008739375) has 39 FDA import refusal record(s) in our database, spanning from 11/13/2014 to 2/1/2023.

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. BEST MEDICAL GMBH's FEI number is 3008739375.

What types of violations has BEST MEDICAL GMBH received?

BEST MEDICAL GMBH has been cited for 3 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 BEST MEDICAL GMBH come from?

All FDA import refusal data for BEST MEDICAL 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.