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HEALTHY LIFE PHARMA PRIVATE LIM

⚠️ Moderate Risk

FEI: 3012573306 • MUMBAI • INDIA

FEI

FEI Number

3012573306

📍

Location

MUMBAI

🇮🇳

Country

INDIA
🏢

Address

NO 401 RICHA B 29 NEW A, , MUMBAI, , India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/17/2016
Latest Refusal
8/17/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/17/2016
61GCA53SULFAMERAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HEALTHY LIFE PHARMA PRIVATE LIM's FDA import refusal history?

HEALTHY LIFE PHARMA PRIVATE LIM (FEI: 3012573306) has 1 FDA import refusal record(s) in our database, spanning from 8/17/2016 to 8/17/2016.

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. HEALTHY LIFE PHARMA PRIVATE LIM's FEI number is 3012573306.

What types of violations has HEALTHY LIFE PHARMA PRIVATE LIM received?

HEALTHY LIFE PHARMA PRIVATE LIM 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 HEALTHY LIFE PHARMA PRIVATE LIM come from?

All FDA import refusal data for HEALTHY LIFE PHARMA PRIVATE LIM 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.