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New Wave Research Division of esi

⚠️ Moderate Risk

FEI: 1000123904 • Fremont, CA • UNITED STATES

FEI

FEI Number

1000123904

📍

Location

Fremont, CA

🇺🇸
🏢

Address

48660 Kato Rd, , Fremont, CA, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/13/2002
Latest Refusal
6/13/2002
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
6/13/2002
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is New Wave Research Division of esi's FDA import refusal history?

New Wave Research Division of esi (FEI: 1000123904) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2002 to 6/13/2002.

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. New Wave Research Division of esi's FEI number is 1000123904.

What types of violations has New Wave Research Division of esi received?

New Wave Research Division of esi 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 New Wave Research Division of esi come from?

All FDA import refusal data for New Wave Research Division of esi 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.