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Bauer & Haselbarth - Chirurg GmbH

⚠️ Moderate Risk

FEI: 3002806450 • Ellerau, Schleswig-Holstein • GERMANY

FEI

FEI Number

3002806450

📍

Location

Ellerau, Schleswig-Holstein

🇩🇪

Country

GERMANY
🏢

Address

Sauerbruchstr. 7, , Ellerau, Schleswig-Holstein, Germany

Moderate Risk

FDA Import Risk Assessment

30.5
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
10/13/2011
Latest Refusal
1/3/2002
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
5.1×10%
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

1183×

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).

27802×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

3411×

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).

Refusal History

DateProductViolationsDivision
10/13/2011
85HDFSPECULUM, VAGINAL, METAL
2780DEVICEGMPS
New Orleans District Office (NOL-DO)
10/13/2011
79EPYSPECULUM, ENT
2780DEVICEGMPS
New Orleans District Office (NOL-DO)
12/12/2002
79FXESPECULUM, NON-ILLUMINATED
118NOT LISTED
New Orleans District Office (NOL-DO)
12/12/2002
78MNGDEVICE, URETHRAL OCCLUSION, FOR INCONTINENCE
118NOT LISTED
New Orleans District Office (NOL-DO)
1/3/2002
78FFRDEVICE, LOCKING, FOR INTESTINAL CLAMP
118NOT LISTED
341REGISTERED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Bauer & Haselbarth - Chirurg GmbH's FDA import refusal history?

Bauer & Haselbarth - Chirurg GmbH (FEI: 3002806450) has 5 FDA import refusal record(s) in our database, spanning from 1/3/2002 to 10/13/2011.

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. Bauer & Haselbarth - Chirurg GmbH's FEI number is 3002806450.

What types of violations has Bauer & Haselbarth - Chirurg GmbH received?

Bauer & Haselbarth - Chirurg 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 Bauer & Haselbarth - Chirurg GmbH come from?

All FDA import refusal data for Bauer & Haselbarth - Chirurg 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.