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PRIMUS GLOVES PRIVATE LTD.

⚠️ Moderate Risk

FEI: 3003529075 • Cochin, Kerala • INDIA

FEI

FEI Number

3003529075

📍

Location

Cochin, Kerala

🇮🇳

Country

INDIA
🏢

Address

Plot No. 14A Cochin Special Economic, Zone, Kakkanad, Cochin, Kerala, India

Moderate Risk

FDA Import Risk Assessment

29.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/27/2017
Latest Refusal
11/15/2001
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
1.9×10%
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

4772×

HOLES

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

3411×

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
10/27/2017
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
Division of Northeast Imports (DNEI)
2/9/2011
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New York District Office (NYK-DO)
11/15/2001
79KGOSURGEON'S GLOVES
477HOLES
Florida District Office (FLA-DO)

Frequently Asked Questions

What is PRIMUS GLOVES PRIVATE LTD.'s FDA import refusal history?

PRIMUS GLOVES PRIVATE LTD. (FEI: 3003529075) has 3 FDA import refusal record(s) in our database, spanning from 11/15/2001 to 10/27/2017.

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. PRIMUS GLOVES PRIVATE LTD.'s FEI number is 3003529075.

What types of violations has PRIMUS GLOVES PRIVATE LTD. received?

PRIMUS GLOVES PRIVATE 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 PRIMUS GLOVES PRIVATE LTD. come from?

All FDA import refusal data for PRIMUS GLOVES PRIVATE 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.