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Diligent Medical Services

⚠️ High Risk

FEI: 3003032798 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3003032798

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Noul Mor, Roas Road, , Sialkot, Punjab, Pakistan

High Risk

FDA Import Risk Assessment

59.2
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

36
Total Refusals
4
Unique Violations
4/26/2012
Latest Refusal
8/26/2010
Earliest Refusal

Score Breakdown

Violation Severity
79.4×40%
Refusal Volume
58.1×30%
Recency
0.0×20%
Frequency
100.0×10%
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

29029×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

4805×

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.

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
4/26/2012
87HRRSCISSORS
2780DEVICEGMPS
Southwest Import District Office (SWI-DO)
2/23/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
2/23/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/10/2012
79GENFORCEPS, GENERAL & PLASTIC SURGERY
479DV QUALITY
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
78FHQHOLDER, NEEDLE
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
87HRRSCISSORS
290DE IMP GMP
Division of Southwest Imports (DSWI)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Division of Southwest Imports (DSWI)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Division of Southwest Imports (DSWI)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Division of Southwest Imports (DSWI)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Division of Southwest Imports (DSWI)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
87HRRSCISSORS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
87HRRSCISSORS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
87HRRSCISSORS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
87HRRSCISSORS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
78FHQHOLDER, NEEDLE
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/6/2012
79HTDFORCEPS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
1/3/2012
79HTDFORCEPS
480STAINSTEEL
Chicago District Office (CHI-DO)
11/9/2011
87HRRSCISSORS
290DE IMP GMP
Southwest Import District Office (SWI-DO)
11/8/2011
79HTDFORCEPS
290DE IMP GMP
Chicago District Office (CHI-DO)
11/7/2011
79HTDFORCEPS
290DE IMP GMP
Chicago District Office (CHI-DO)
11/7/2011
79HTDFORCEPS
290DE IMP GMP
Chicago District Office (CHI-DO)
9/10/2011
79FXGSPECULA ACCESSORIES
480STAINSTEEL
Chicago District Office (CHI-DO)
9/10/2011
76EIGRETRACTOR, ALL TYPES
480STAINSTEEL
Chicago District Office (CHI-DO)
9/10/2011
78FHQHOLDER, NEEDLE
480STAINSTEEL
Chicago District Office (CHI-DO)
9/10/2011
79HTDFORCEPS
480STAINSTEEL
Chicago District Office (CHI-DO)
8/26/2010
79GENFORCEPS, GENERAL & PLASTIC SURGERY
290DE IMP GMP
Southwest Import District Office (SWI-DO)
8/26/2010
76EGNSCISSORS, SURGICAL TISSUE, DENTAL
290DE IMP GMP
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Diligent Medical Services's FDA import refusal history?

Diligent Medical Services (FEI: 3003032798) has 36 FDA import refusal record(s) in our database, spanning from 8/26/2010 to 4/26/2012.

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. Diligent Medical Services's FEI number is 3003032798.

What types of violations has Diligent Medical Services received?

Diligent Medical Services has been cited for 4 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 Diligent Medical Services come from?

All FDA import refusal data for Diligent Medical Services 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.