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Health Care Products

⚠️ Moderate Risk

FEI: 3006103123 • Noida, Uttar Pradesh • INDIA

FEI

FEI Number

3006103123

📍

Location

Noida, Uttar Pradesh

🇮🇳

Country

INDIA
🏢

Address

1 33a, , Noida, Uttar Pradesh, India

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
2
Unique Violations
3/7/2007
Latest Refusal
3/7/2007
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

4771×

HOLES

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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/7/2007
85HISCONDOM
477HOLES
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Health Care Products's FDA import refusal history?

Health Care Products (FEI: 3006103123) has 1 FDA import refusal record(s) in our database, spanning from 3/7/2007 to 3/7/2007.

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. Health Care Products's FEI number is 3006103123.

What types of violations has Health Care Products received?

Health Care Products 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 Health Care Products come from?

All FDA import refusal data for Health Care Products 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.