ImportRefusal LogoImportRefusal

RECKITT BENCKISER INDIA

⚠️ Moderate Risk

FEI: 3013440475 • Mysore, Karnataka • INDIA

FEI

FEI Number

3013440475

📍

Location

Mysore, Karnataka

🇮🇳

Country

INDIA
🏢

Address

62 Limited 61, Manandavadi Road, Mysore, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/27/2017
Latest Refusal
4/24/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
7/27/2017
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northeast Imports (DNEI)
7/27/2017
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northeast Imports (DNEI)
4/24/2017
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is RECKITT BENCKISER INDIA's FDA import refusal history?

RECKITT BENCKISER INDIA (FEI: 3013440475) has 3 FDA import refusal record(s) in our database, spanning from 4/24/2017 to 7/27/2017.

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. RECKITT BENCKISER INDIA's FEI number is 3013440475.

What types of violations has RECKITT BENCKISER INDIA received?

RECKITT BENCKISER INDIA 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 RECKITT BENCKISER INDIA come from?

All FDA import refusal data for RECKITT BENCKISER INDIA 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.