Richard Wolf GmbH
⚠️ Moderate Risk
FEI: 3002808001 • Knittlingen, Baden-Wurttemberg • GERMANY
FEI Number
3002808001
Location
Knittlingen, Baden-Wurttemberg
Country
GERMANYAddress
Pforzheimer Str. 32, , Knittlingen, 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
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.
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 |
|---|---|---|---|
| 4/24/2018 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | Division of West Coast Imports (DWCI) | |
| 4/24/2018 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | Division of West Coast Imports (DWCI) | |
| 4/23/2012 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Cincinnati District Office (CIN-DO) | |
| 5/31/2002 | 78GCMENDOSCOPE, RIGID | 508NO 510(K) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Richard Wolf GmbH's FDA import refusal history?
Richard Wolf GmbH (FEI: 3002808001) has 4 FDA import refusal record(s) in our database, spanning from 5/31/2002 to 4/24/2018.
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. Richard Wolf GmbH's FEI number is 3002808001.
What types of violations has Richard Wolf GmbH received?
Richard 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 Richard Wolf GmbH come from?
All FDA import refusal data for Richard 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.