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Messrs Richbolt En

⚠️ Moderate Risk

FEI: 3004730373 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3004730373

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Raja Road, , Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/15/2005
Latest Refusal
9/21/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4802×

STAINSTEEL

The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.

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
12/15/2005
87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
118NOT LISTED
480STAINSTEEL
New Orleans District Office (NOL-DO)
9/21/2005
79HTCPLIERS, SURGICAL
480STAINSTEEL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Messrs Richbolt En's FDA import refusal history?

Messrs Richbolt En (FEI: 3004730373) has 2 FDA import refusal record(s) in our database, spanning from 9/21/2005 to 12/15/2005.

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. Messrs Richbolt En's FEI number is 3004730373.

What types of violations has Messrs Richbolt En received?

Messrs Richbolt En 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 Messrs Richbolt En come from?

All FDA import refusal data for Messrs Richbolt En 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.