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Gandhar Oil Refinery (India) limited

⚠️ Moderate Risk

FEI: 3015986431 • Panvel, Maharashtra • INDIA

FEI

FEI Number

3015986431

📍

Location

Panvel, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

T - 10 Taloja Road, , Panvel, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

43.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/29/2025
Latest Refusal
10/29/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
95.5×20%
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

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).

Refusal History

DateProductViolationsDivision
10/29/2025
63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Gandhar Oil Refinery (India) limited's FDA import refusal history?

Gandhar Oil Refinery (India) limited (FEI: 3015986431) has 1 FDA import refusal record(s) in our database, spanning from 10/29/2025 to 10/29/2025.

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. Gandhar Oil Refinery (India) limited's FEI number is 3015986431.

What types of violations has Gandhar Oil Refinery (India) limited received?

Gandhar Oil Refinery (India) limited 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 Gandhar Oil Refinery (India) limited come from?

All FDA import refusal data for Gandhar Oil Refinery (India) limited 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.