Henke-Sass & Wolf Gmbh
⚠️ Moderate Risk
FEI: 3007130719 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3007130719
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Keltenstr. 1, , Tuttlingen, 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
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).
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2022 | 78FAJCYSTOSCOPE, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 12/14/2022 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 9/30/2022 | 87HRXARTHROSCOPE AND ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/5/2018 | 78FAJCYSTOSCOPE, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/10/2017 | 68XYY01CATTLE DEVICE/DIAG PROD FOR ANIMAL | Division of Southwest Imports (DSWI) | |
| 5/2/2013 | 87HRXARTHROSCOPE AND ACCESSORIES | Los Angeles District Office (LOS-DO) | |
| 11/15/2010 | 78FEDSHEATH, FOR ENDOSCOPE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Henke-Sass & Wolf Gmbh's FDA import refusal history?
Henke-Sass & Wolf Gmbh (FEI: 3007130719) has 7 FDA import refusal record(s) in our database, spanning from 11/15/2010 to 12/14/2022.
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. Henke-Sass & Wolf Gmbh's FEI number is 3007130719.
What types of violations has Henke-Sass & Wolf Gmbh received?
Henke-Sass & Wolf Gmbh has been cited for 5 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 Henke-Sass & Wolf Gmbh come from?
All FDA import refusal data for Henke-Sass & Wolf 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.