Technimen Agha Pvt Ltd

⚠️ High Risk

FEI: 3007057998 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3007057998

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN

🏢

Address

Kashmir Road, , Sialkot, Punjab, Pakistan

High Risk

FDA Import Risk Assessment

54.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/14/2011

Latest Refusal

5/31/2011

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

42.5×30%

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

Violation Summary

29012×

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).

4801×

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.

Refusal History

Date	Product	Violations	Division
6/14/2011	79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	78FHQHOLDER, NEEDLE	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	79HXDCLAMP	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	79LRWSCISSORS, GENERAL USE, SURGICAL	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	79GDZHANDLE, SCALPEL	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	78FHQHOLDER, NEEDLE	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	79HXDCLAMP	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	79LRWSCISSORS, GENERAL USE, SURGICAL	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/14/2011	79GDZHANDLE, SCALPEL	290DE IMP GMP	Cincinnati District Office (CIN-DO)
5/31/2011	85HDFSPECULUM, VAGINAL, METAL	480STAINSTEEL	New York District Office (NYK-DO)

Frequently Asked Questions

What is Technimen Agha Pvt Ltd's FDA import refusal history?

Technimen Agha Pvt Ltd (FEI: 3007057998) has 13 FDA import refusal record(s) in our database, spanning from 5/31/2011 to 6/14/2011.

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. Technimen Agha Pvt Ltd's FEI number is 3007057998.

What types of violations has Technimen Agha Pvt Ltd received?

Technimen Agha Pvt Ltd 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 Technimen Agha Pvt Ltd come from?

All FDA import refusal data for Technimen Agha 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.