ImportRefusal LogoImportRefusal

FLUKE TECHNOLOGIES PRIVATE LIMITED

⚠️ Moderate Risk

FEI: 3014247097 • Bhiwandi, Maharashtra • INDIA

FEI

FEI Number

3014247097

📍

Location

Bhiwandi, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

53 Building 46, Anjur Dapoda Road, Bhiwandi, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

29.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/16/2022
Latest Refusal
2/16/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
7.9×20%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
2/16/2022
95REKRESEARCH LASER, SCIENTIFIC, LABORATORY LASER PRODUCTS
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FLUKE TECHNOLOGIES PRIVATE LIMITED's FDA import refusal history?

FLUKE TECHNOLOGIES PRIVATE LIMITED (FEI: 3014247097) has 1 FDA import refusal record(s) in our database, spanning from 2/16/2022 to 2/16/2022.

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. FLUKE TECHNOLOGIES PRIVATE LIMITED's FEI number is 3014247097.

What types of violations has FLUKE TECHNOLOGIES PRIVATE LIMITED received?

FLUKE TECHNOLOGIES PRIVATE LIMITED 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 FLUKE TECHNOLOGIES PRIVATE LIMITED come from?

All FDA import refusal data for FLUKE TECHNOLOGIES PRIVATE LIMITED 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.