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Royal Castor Products Pvt. Ltd.

⚠️ Moderate Risk

FEI: 3002611543 • Gujarat, GJ • INDIA

FEI

FEI Number

3002611543

📍

Location

Gujarat, GJ

🇮🇳

Country

INDIA
🏢

Address

Royal House, Radhanpur Roadnear Octroi, , Gujarat, GJ, 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
2
Unique Violations
3/3/2003
Latest Refusal
3/3/2003
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

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
3/3/2003
63HAS08CASTOR OIL (CATHARTIC)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Royal Castor Products Pvt. Ltd.'s FDA import refusal history?

Royal Castor Products Pvt. Ltd. (FEI: 3002611543) has 1 FDA import refusal record(s) in our database, spanning from 3/3/2003 to 3/3/2003.

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. Royal Castor Products Pvt. Ltd.'s FEI number is 3002611543.

What types of violations has Royal Castor Products Pvt. Ltd. received?

Royal Castor Products Pvt. Ltd. has been cited for 2 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 Royal Castor Products Pvt. Ltd. come from?

All FDA import refusal data for Royal Castor Products Pvt. 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.