Scholly Fiberoptic Gmbh
⚠️ Moderate Risk
FEI: 3002808088 • Denzlingen, Baden-Wurttemberg • GERMANY
FEI Number
3002808088
Location
Denzlingen, Baden-Wurttemberg
Country
GERMANYAddress
Robert-Bosch-Str. 1-3, , Denzlingen, 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
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).
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.
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(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/30/2013 | 87HRXARTHROSCOPE AND ACCESSORIES | New Orleans District Office (NOL-DO) | |
| 9/27/2013 | 87HRXARTHROSCOPE AND ACCESSORIES | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 12/28/2011 | 79NAYSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 8/3/2009 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | New Orleans District Office (NOL-DO) | |
| 5/10/2007 | 78KOGENDOSCOPE AND/OR ACCESSORIES | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Scholly Fiberoptic Gmbh's FDA import refusal history?
Scholly Fiberoptic Gmbh (FEI: 3002808088) has 5 FDA import refusal record(s) in our database, spanning from 5/10/2007 to 9/30/2013.
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. Scholly Fiberoptic Gmbh's FEI number is 3002808088.
What types of violations has Scholly Fiberoptic Gmbh received?
Scholly Fiberoptic 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 Scholly Fiberoptic Gmbh come from?
All FDA import refusal data for Scholly Fiberoptic 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.