Bausch & Lomb
⚠️ Moderate Risk
FEI: 3002642243 • Livingston • UNITED KINGDOM
FEI Number
3002642243
Location
Livingston
Country
UNITED KINGDOMAddress
6-8, , Livingston, , United Kingdom
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bausch & Lomb's FDA import refusal history?
Bausch & Lomb (FEI: 3002642243) has 7 FDA import refusal record(s) in our database, spanning from 8/21/2013 to 8/27/2013.
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. Bausch & Lomb's FEI number is 3002642243.
What types of violations has Bausch & Lomb received?
Bausch & Lomb has been cited for 1 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 Bausch & Lomb come from?
All FDA import refusal data for Bausch & Lomb 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.