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Newport Corp

⚠️ Moderate Risk

FEI: 3006486093 • Mountain View, CA • UNITED STATES

FEI

FEI Number

3006486093

📍

Location

Mountain View, CA

🇺🇸
🏢

Address

1330 Terra Bella Ave # 15, , Mountain View, CA, United States

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
11/10/2010
Latest Refusal
11/10/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2901×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

Refusal History

DateProductViolationsDivision
11/10/2010
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
290DE IMP GMP
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Newport Corp's FDA import refusal history?

Newport Corp (FEI: 3006486093) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2010 to 11/10/2010.

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. Newport Corp's FEI number is 3006486093.

What types of violations has Newport Corp received?

Newport Corp 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 Newport Corp come from?

All FDA import refusal data for Newport Corp 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.