Carl Zeiss Meditec Inc.
⚠️ Moderate Risk
FEI: 2918630 • Dublin, CA • UNITED STATES
FEI Number
2918630
Location
Dublin, CA
Country
UNITED STATESAddress
5300 Central Pkwy, , Dublin, CA, United States
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2017 | 86HPTPERIMETER, AUTOMATIC, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 1/28/2015 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | Division of Northeast Imports (DNEI) | |
| 1/28/2015 | 86OBOTOMOGRAPHY, OPTICAL COHERENCE | Division of Northeast Imports (DNEI) | |
| 8/25/2011 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/25/2011 | 86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/25/2011 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Carl Zeiss Meditec Inc.'s FDA import refusal history?
Carl Zeiss Meditec Inc. (FEI: 2918630) has 6 FDA import refusal record(s) in our database, spanning from 8/25/2011 to 2/27/2017.
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 Meditec Inc.'s FEI number is 2918630.
What types of violations has Carl Zeiss Meditec Inc. received?
Carl Zeiss Meditec Inc. 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 Meditec Inc. come from?
All FDA import refusal data for Carl Zeiss Meditec Inc. 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.