Bausch & Lomb Incorporated
⚠️ High Risk
FEI: 1000113778 • Tampa, FL • UNITED STATES
FEI Number
1000113778
Location
Tampa, FL
Country
UNITED STATESAddress
8500 Hidden River Pkwy, , Tampa, FL, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2025 | 65FAK06WATER, PURIFIED (EYEWASH) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2012 | 64LCK37HYDROCORTISONE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 64LCK37HYDROCORTISONE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/31/2007 | 60CIY09PHENYLEPHRINE HCL (ADRENERGIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bausch & Lomb Incorporated's FDA import refusal history?
Bausch & Lomb Incorporated (FEI: 1000113778) has 4 FDA import refusal record(s) in our database, spanning from 1/31/2007 to 12/22/2025.
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 Incorporated's FEI number is 1000113778.
What types of violations has Bausch & Lomb Incorporated received?
Bausch & Lomb Incorporated has been cited for 2 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 Incorporated come from?
All FDA import refusal data for Bausch & Lomb Incorporated 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.