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Rani Drug House

⚠️ Moderate Risk

FEI: 3005734324 • Nellayi, Kerala • INDIA

FEI

FEI Number

3005734324

📍

Location

Nellayi, Kerala

🇮🇳

Country

INDIA
🏢

Address

Trichur (Thrissur) District, , Nellayi, Kerala, India

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/6/2006
Latest Refusal
7/6/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
7/6/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Rani Drug House's FDA import refusal history?

Rani Drug House (FEI: 3005734324) has 1 FDA import refusal record(s) in our database, spanning from 7/6/2006 to 7/6/2006.

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. Rani Drug House's FEI number is 3005734324.

What types of violations has Rani Drug House received?

Rani Drug House 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 Rani Drug House come from?

All FDA import refusal data for Rani Drug House 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.