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Amishi Drug and Chemicals Ltd.

⚠️ Moderate Risk

FEI: 3004669674 • Ahmedabad, Gujarat • INDIA

FEI

FEI Number

3004669674

📍

Location

Ahmedabad, Gujarat

🇮🇳

Country

INDIA
🏢

Address

Phase 4, GIDC, Naroda, Ahmedabad, Gujarat, India

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/4/2015
Latest Refusal
6/4/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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.

Refusal History

DateProductViolationsDivision
6/4/2015
61HIY99ANTI-BACTERIAL, N.E.C.
16DIRECTIONS
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Amishi Drug and Chemicals Ltd.'s FDA import refusal history?

Amishi Drug and Chemicals Ltd. (FEI: 3004669674) has 1 FDA import refusal record(s) in our database, spanning from 6/4/2015 to 6/4/2015.

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. Amishi Drug and Chemicals Ltd.'s FEI number is 3004669674.

What types of violations has Amishi Drug and Chemicals Ltd. received?

Amishi Drug and Chemicals Ltd. 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 Amishi Drug and Chemicals Ltd. come from?

All FDA import refusal data for Amishi Drug and Chemicals Ltd. 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.