Bausch & Lomb De Mexico
⚠️ Moderate Risk
FEI: 3003423728 • Tlalnepantla • MEXICO
FEI Number
3003423728
Location
Tlalnepantla
Country
MEXICOAddress
Av Presidente Juarez #2007, , Tlalnepantla, , Mexico
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Bausch & Lomb De Mexico's FDA import refusal history?
Bausch & Lomb De Mexico (FEI: 3003423728) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2005 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. Bausch & Lomb De Mexico's FEI number is 3003423728.
What types of violations has Bausch & Lomb De Mexico received?
Bausch & Lomb De Mexico 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 Bausch & Lomb De Mexico come from?
All FDA import refusal data for Bausch & Lomb De Mexico 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.