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FEMININE HYGIENE PRODUCTS PVT. LTD.

✅ Low Risk

FEI: 3004941681 • Pune, Maharashtra • INDIA

FEI

FEI Number

3004941681

📍

Location

Pune, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

599 Vijay House, 3rd Floor; Sachapir Street, Pune, Maharashtra, India

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
1/27/2005
Latest Refusal
1/27/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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).

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
1/27/2005
85HHDPAD, MENSTRUAL, UNSCENTED
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is FEMININE HYGIENE PRODUCTS PVT. LTD.'s FDA import refusal history?

FEMININE HYGIENE PRODUCTS PVT. LTD. (FEI: 3004941681) has 1 FDA import refusal record(s) in our database, spanning from 1/27/2005 to 1/27/2005.

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. FEMININE HYGIENE PRODUCTS PVT. LTD.'s FEI number is 3004941681.

What types of violations has FEMININE HYGIENE PRODUCTS PVT. LTD. received?

FEMININE HYGIENE 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 FEMININE HYGIENE PRODUCTS PVT. LTD. come from?

All FDA import refusal data for FEMININE HYGIENE 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.