Pierenkemper Gmbh
⚠️ Moderate Risk
FEI: 3005923596 • Ehringshausen, Hassia • GERMANY
FEI Number
3005923596
Location
Ehringshausen, Hassia
Country
GERMANYAddress
Wetzlarer Str. 41-43, , Ehringshausen, Hassia, 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
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.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/23/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 11/27/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/16/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/20/2013 | 73BWKSTIMULATOR, ELECTRO-ACUPUNCTURE | Cincinnati District Office (CIN-DO) | |
| 9/6/2012 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | New York District Office (NYK-DO) | |
| 9/6/2012 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | New York District Office (NYK-DO) | |
| 8/28/2012 | 80BWJLOCATOR, ACUPUNCTURE POINT | New York District Office (NYK-DO) | |
| 9/15/2011 | 80BWJLOCATOR, ACUPUNCTURE POINT | New York District Office (NYK-DO) | |
| 2/2/2011 | 84GWRGENERATOR, ELECTROENCEPHALOGRAPH TEST SIGNAL | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 80LDQDEVICE, GENERAL MEDICAL | New Orleans District Office (NOL-DO) | |
| 10/19/2009 | 80BWJLOCATOR, ACUPUNCTURE POINT | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pierenkemper Gmbh's FDA import refusal history?
Pierenkemper Gmbh (FEI: 3005923596) has 12 FDA import refusal record(s) in our database, spanning from 10/19/2009 to 9/28/2020.
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. Pierenkemper Gmbh's FEI number is 3005923596.
What types of violations has Pierenkemper Gmbh received?
Pierenkemper Gmbh 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 Pierenkemper Gmbh come from?
All FDA import refusal data for Pierenkemper 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.