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RAINBOW PASSION

⚠️ High Risk

FEI: 3014654572 • Kotdwar • INDIA

FEI

FEI Number

3014654572

📍

Location

Kotdwar

🇮🇳

Country

INDIA
🏢

Address

D-16 17 Siggadi Growthcentre, , Kotdwar, , India

High Risk

FDA Import Risk Assessment

54.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
9/11/2024
Latest Refusal
6/17/2024
Earliest Refusal

Score Breakdown

Violation Severity
76.0×40%
Refusal Volume
22.3×30%
Recency
73.3×20%
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).

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
9/11/2024
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
75UNAPPROVED
Division of Northeast Imports (DNEI)
9/3/2024
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
178COL ADDED
75UNAPPROVED
Division of Northeast Imports (DNEI)
6/17/2024
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is RAINBOW PASSION's FDA import refusal history?

RAINBOW PASSION (FEI: 3014654572) has 3 FDA import refusal record(s) in our database, spanning from 6/17/2024 to 9/11/2024.

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. RAINBOW PASSION's FEI number is 3014654572.

What types of violations has RAINBOW PASSION received?

RAINBOW PASSION has been cited for 3 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 RAINBOW PASSION come from?

All FDA import refusal data for RAINBOW PASSION 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.