Bausch & Lomb, Inc.
⚠️ Moderate Risk
FEI: 1000119305 • Manchester, MO • UNITED STATES
FEI Number
1000119305
Location
Manchester, MO
Country
UNITED STATESAddress
499 Sovereign Ct, , Manchester, MO, 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
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
Frequently Asked Questions
What is Bausch & Lomb, Inc.'s FDA import refusal history?
Bausch & Lomb, Inc. (FEI: 1000119305) has 2 FDA import refusal record(s) in our database, spanning from 9/26/2018 to 9/2/2020.
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, Inc.'s FEI number is 1000119305.
What types of violations has Bausch & Lomb, Inc. received?
Bausch & Lomb, Inc. 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, Inc. come from?
All FDA import refusal data for Bausch & Lomb, 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.