Ciba Vision Corporation
⚠️ Moderate Risk
FEI: 1000115040 • Des Plaines, IL • UNITED STATES
FEI Number
1000115040
Location
Des Plaines, IL
Country
UNITED STATESAddress
333 Howard Ave, , Des Plaines, IL, 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
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
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).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3724DEVGMPS | Atlanta District Office (ATL-DO) |
| 6/13/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3724DEVGMPS | Atlanta District Office (ATL-DO) |
| 1/6/2005 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 5/21/2004 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 310POISONOUS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ciba Vision Corporation's FDA import refusal history?
Ciba Vision Corporation (FEI: 1000115040) has 4 FDA import refusal record(s) in our database, spanning from 5/21/2004 to 6/13/2014.
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. Ciba Vision Corporation's FEI number is 1000115040.
What types of violations has Ciba Vision Corporation received?
Ciba Vision Corporation 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 Ciba Vision Corporation come from?
All FDA import refusal data for Ciba Vision Corporation 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.