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Healwell Homeo Private Limited

⚠️ High Risk

FEI: 3028192440 • Ahmedabad, Gujarat • INDIA

FEI

FEI Number

3028192440

📍

Location

Ahmedabad, Gujarat

🇮🇳

Country

INDIA
🏢

Address

Plot No. 215/1 220/1 & 221/1, Village Indrad, Tal Kadi, Dist Mehsana, Ahmedabad, Gujarat, India

High Risk

FDA Import Risk Assessment

53.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/15/2025
Latest Refusal
4/15/2025
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
70.0×20%
Frequency
20.0×10%
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

272×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
4/15/2025
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Northeast Imports (DNEI)
4/15/2025
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Healwell Homeo Private Limited's FDA import refusal history?

Healwell Homeo Private Limited (FEI: 3028192440) has 2 FDA import refusal record(s) in our database, spanning from 4/15/2025 to 4/15/2025.

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. Healwell Homeo Private Limited's FEI number is 3028192440.

What types of violations has Healwell Homeo Private Limited received?

Healwell Homeo 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 Healwell Homeo Private Limited come from?

All FDA import refusal data for Healwell Homeo 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.