ImportRefusal LogoImportRefusal

Panchsheel Organics Limited

✅ Low Risk

FEI: 3004096770 • Indore, Madhya Pradesh • INDIA

FEI

FEI Number

3004096770

📍

Location

Indore, Madhya Pradesh

🇮🇳

Country

INDIA
🏢

Address

B7 Sector C, Sanwar Road Industrial area, Indore, Madhya Pradesh, India

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
1/4/2012
Latest Refusal
1/4/2012
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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).

28801×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

Refusal History

DateProductViolationsDivision
1/4/2012
60LCS82PHENAZOPYRIDINE HCL (ANALGESIC)
118NOT LISTED
2880RXCOMPOUND
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Panchsheel Organics Limited's FDA import refusal history?

Panchsheel Organics Limited (FEI: 3004096770) has 1 FDA import refusal record(s) in our database, spanning from 1/4/2012 to 1/4/2012.

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. Panchsheel Organics Limited's FEI number is 3004096770.

What types of violations has Panchsheel Organics Limited received?

Panchsheel Organics Limited 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 Panchsheel Organics Limited come from?

All FDA import refusal data for Panchsheel Organics 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.