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TEGAMEN SAFETY PRODUCTS PVT. LTD.

⚠️ High Risk

FEI: 3024712919 • Alwar, Rajasthan • INDIA

FEI

FEI Number

3024712919

📍

Location

Alwar, Rajasthan

🇮🇳

Country

INDIA
🏢

Address

Sp7-52, Riico Industrial Area, Ghiloth, Alwar, Rajasthan, India

High Risk

FDA Import Risk Assessment

52.9
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
2
Unique Violations
9/3/2025
Latest Refusal
4/4/2024
Earliest Refusal

Score Breakdown

Violation Severity
55.5×40%
Refusal Volume
33.5×30%
Recency
78.6×20%
Frequency
49.4×10%
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

4777×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

3414×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
9/3/2025
80FMCGLOVE, PATIENT EXAMINATION
477HOLES
Division of West Coast Imports (DWCI)
9/3/2025
80FMCGLOVE, PATIENT EXAMINATION
477HOLES
Division of West Coast Imports (DWCI)
9/3/2025
80FMCGLOVE, PATIENT EXAMINATION
477HOLES
Division of West Coast Imports (DWCI)
4/4/2024
80LZAGLOVE, PATIENT EXAMINATION, POLY
341REGISTERED
477HOLES
Division of West Coast Imports (DWCI)
4/4/2024
80LZAGLOVE, PATIENT EXAMINATION, POLY
341REGISTERED
477HOLES
Division of West Coast Imports (DWCI)
4/4/2024
80LZAGLOVE, PATIENT EXAMINATION, POLY
341REGISTERED
477HOLES
Division of West Coast Imports (DWCI)
4/4/2024
80LZAGLOVE, PATIENT EXAMINATION, POLY
341REGISTERED
477HOLES
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is TEGAMEN SAFETY PRODUCTS PVT. LTD.'s FDA import refusal history?

TEGAMEN SAFETY PRODUCTS PVT. LTD. (FEI: 3024712919) has 7 FDA import refusal record(s) in our database, spanning from 4/4/2024 to 9/3/2025.

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. TEGAMEN SAFETY PRODUCTS PVT. LTD.'s FEI number is 3024712919.

What types of violations has TEGAMEN SAFETY PRODUCTS PVT. LTD. received?

TEGAMEN SAFETY PRODUCTS PVT. LTD. has been cited for 2 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 TEGAMEN SAFETY PRODUCTS PVT. LTD. come from?

All FDA import refusal data for TEGAMEN SAFETY PRODUCTS PVT. LTD. 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.