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Roop Herbal Life

⚠️ Moderate Risk

FEI: 3004738202 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3004738202

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

303 Shrikant Chambers, , Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
7/17/2007
Latest Refusal
12/15/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

3102×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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.

Refusal History

DateProductViolationsDivision
7/17/2007
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
310POISONOUS
New York District Office (NYK-DO)
7/17/2007
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
310POISONOUS
New York District Office (NYK-DO)
12/15/2006
65LAK06CALAMINE (PROTECTANT)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Roop Herbal Life's FDA import refusal history?

Roop Herbal Life (FEI: 3004738202) has 3 FDA import refusal record(s) in our database, spanning from 12/15/2006 to 7/17/2007.

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. Roop Herbal Life's FEI number is 3004738202.

What types of violations has Roop Herbal Life received?

Roop Herbal Life 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 Roop Herbal Life come from?

All FDA import refusal data for Roop Herbal Life 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.