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Palm Fibre (India) Pvt Ltd.

✅ Low Risk

FEI: 3005059121 • Pathirappally, Kerala • INDIA

FEI

FEI Number

3005059121

📍

Location

Pathirappally, Kerala

🇮🇳

Country

INDIA
🏢

Address

Thuravoorthuravoor, , Pathirappally, Kerala, India

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/10/2005
Latest Refusal
6/10/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

Refusal History

DateProductViolationsDivision
6/10/2005
54FGL99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Palm Fibre (India) Pvt Ltd.'s FDA import refusal history?

Palm Fibre (India) Pvt Ltd. (FEI: 3005059121) has 1 FDA import refusal record(s) in our database, spanning from 6/10/2005 to 6/10/2005.

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. Palm Fibre (India) Pvt Ltd.'s FEI number is 3005059121.

What types of violations has Palm Fibre (India) Pvt Ltd. received?

Palm Fibre (India) Pvt 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 Palm Fibre (India) Pvt Ltd. come from?

All FDA import refusal data for Palm Fibre (India) 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.