PAJUNK GMBH MEDIZINTECHNOLOGIE
⚠️ Moderate Risk
FEI: 3002807847 • Geisingen, Baden-Wurttemberg • GERMANY
FEI Number
3002807847
Location
Geisingen, Baden-Wurttemberg
Country
GERMANYAddress
Karl-Hall-Str. 1, , Geisingen, Baden-Wurttemberg, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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).
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2009 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 341REGISTERED | New York District Office (NYK-DO) |
| 2/23/2005 | 73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 2/7/2005 | 73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 2/7/2005 | 73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 1/25/2005 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 2780DEVICEGMPS | Philadelphia District Office (PHI-DO) |
| 6/20/2003 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is PAJUNK GMBH MEDIZINTECHNOLOGIE's FDA import refusal history?
PAJUNK GMBH MEDIZINTECHNOLOGIE (FEI: 3002807847) has 6 FDA import refusal record(s) in our database, spanning from 6/20/2003 to 12/9/2009.
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. PAJUNK GMBH MEDIZINTECHNOLOGIE's FEI number is 3002807847.
What types of violations has PAJUNK GMBH MEDIZINTECHNOLOGIE received?
PAJUNK GMBH MEDIZINTECHNOLOGIE has been cited for 4 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 PAJUNK GMBH MEDIZINTECHNOLOGIE come from?
All FDA import refusal data for PAJUNK GMBH MEDIZINTECHNOLOGIE 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.