ImportRefusal LogoImportRefusal

P Gopaldas

⚠️ Moderate Risk

FEI: 1000214007 • Kowloon • HONG KONG

FEI

FEI Number

1000214007

📍

Location

Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Po Box 6570, , Kowloon, , Hong Kong

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
6/22/2016
Latest Refusal
6/22/2016
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
6/22/2016
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is P Gopaldas's FDA import refusal history?

P Gopaldas (FEI: 1000214007) has 1 FDA import refusal record(s) in our database, spanning from 6/22/2016 to 6/22/2016.

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. P Gopaldas's FEI number is 1000214007.

What types of violations has P Gopaldas received?

P Gopaldas 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 P Gopaldas come from?

All FDA import refusal data for P Gopaldas 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.