Carl Zeiss Vision GmbH
⚠️ Moderate Risk
FEI: 3002398337 • Aalen, Baden-Wurttemberg • GERMANY
FEI Number
3002398337
Location
Aalen, Baden-Wurttemberg
Country
GERMANYAddress
Turnstrasse 27, , Aalen, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2022 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 237NO PMA | Division of Southeast Imports (DSEI) |
| 9/26/2022 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/5/2014 | 86NQEMICROSCOPE, SPECULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/27/2013 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 235NOT IMPACT | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Carl Zeiss Vision GmbH's FDA import refusal history?
Carl Zeiss Vision GmbH (FEI: 3002398337) has 4 FDA import refusal record(s) in our database, spanning from 6/27/2013 to 9/26/2022.
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. Carl Zeiss Vision GmbH's FEI number is 3002398337.
What types of violations has Carl Zeiss Vision GmbH received?
Carl Zeiss Vision GmbH has been cited for 3 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 Carl Zeiss Vision GmbH come from?
All FDA import refusal data for Carl Zeiss Vision 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.