Wesley Jessen Corporation
⚠️ High Risk
FEI: 1000658226 • Des Plaines, IL • UNITED STATES
FEI Number
1000658226
Location
Des Plaines, IL
Country
UNITED STATESAddress
333 Howard Ave, , Des Plaines, IL, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2005 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 1/6/2005 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/4/2005 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/9/2004 | 86MVNLENS, CONTACT (DISPOSABLE) | 310POISONOUS | New York District Office (NYK-DO) |
| 11/8/2004 | 86MVNLENS, CONTACT (DISPOSABLE) | 310POISONOUS | New York District Office (NYK-DO) |
| 11/8/2004 | 86MVNLENS, CONTACT (DISPOSABLE) | 310POISONOUS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wesley Jessen Corporation's FDA import refusal history?
Wesley Jessen Corporation (FEI: 1000658226) has 6 FDA import refusal record(s) in our database, spanning from 11/8/2004 to 10/25/2005.
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. Wesley Jessen Corporation's FEI number is 1000658226.
What types of violations has Wesley Jessen Corporation received?
Wesley Jessen 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 Wesley Jessen Corporation come from?
All FDA import refusal data for Wesley Jessen 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.