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Ashu Herbal

⚠️ Moderate Risk

FEI: 3008921059 • Navagher • INDIA

FEI

FEI Number

3008921059

📍

Location

Navagher

🇮🇳

Country

INDIA
🏢

Address

3 Shrepal Industrial Estate 2nd, , Navagher, , India

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
8/31/2012
Latest Refusal
8/31/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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.

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).

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
8/31/2012
66VBH99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
178COL ADDED
335LACKS N/C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ashu Herbal's FDA import refusal history?

Ashu Herbal (FEI: 3008921059) has 1 FDA import refusal record(s) in our database, spanning from 8/31/2012 to 8/31/2012.

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. Ashu Herbal's FEI number is 3008921059.

What types of violations has Ashu Herbal received?

Ashu Herbal 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 Ashu Herbal come from?

All FDA import refusal data for Ashu Herbal 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.