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Manner Products

⚠️ Moderate Risk

FEI: 3004172970 • Sialkot • PAKISTAN

FEI

FEI Number

3004172970

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Muhammed Pura, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

38.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/19/2007
Latest Refusal
7/20/2007
Earliest Refusal

Score Breakdown

Violation Severity
72.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4803×

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
11/19/2007
78FHQHOLDER, NEEDLE
480STAINSTEEL
Chicago District Office (CHI-DO)
11/19/2007
79HTDFORCEPS
480STAINSTEEL
Chicago District Office (CHI-DO)
7/20/2007
79HTDFORCEPS
118NOT LISTED
480STAINSTEEL
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Manner Products's FDA import refusal history?

Manner Products (FEI: 3004172970) has 3 FDA import refusal record(s) in our database, spanning from 7/20/2007 to 11/19/2007.

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. Manner Products's FEI number is 3004172970.

What types of violations has Manner Products received?

Manner Products 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 Manner Products come from?

All FDA import refusal data for Manner Products 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.