Y.Z. Corporation

⚠️ Moderate Risk

FEI: 3001146947 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3001146947

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN

🏢

Address

A-8 Industrial Estate, , Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

46.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/6/2012

Latest Refusal

11/12/2009

Earliest Refusal

Score Breakdown

Violation Severity

51.2×40%

Refusal Volume

53.6×30%

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

11827×

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).

34127×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

29018×

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).

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.

Refusal History

Date	Product	Violations	Division
2/6/2012	76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING	118NOT LISTED 341REGISTERED	Chicago District Office (CHI-DO)
2/6/2012	76EEFCLAMP, RUBBER DAM	118NOT LISTED 341REGISTERED	Chicago District Office (CHI-DO)
2/6/2012	76EIXPROBE, PERIODONTIC	118NOT LISTED 341REGISTERED	Chicago District Office (CHI-DO)
2/6/2012	76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL	118NOT LISTED 341REGISTERED	Chicago District Office (CHI-DO)
2/6/2012	76EMKCURETTE, SURGICAL, DENTAL	118NOT LISTED 341REGISTERED	Chicago District Office (CHI-DO)
2/6/2012	76EBHMATERIAL, IMPRESSION TRAY, RESIN	118NOT LISTED 341REGISTERED	Chicago District Office (CHI-DO)
11/10/2011	76DZPINSTRUMENT, DIAMOND, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76DZPINSTRUMENT, DIAMOND, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EFLFORCEPS, DRESSING, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76EJYPLIERS, OPERATIVE	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76OFXGENERAL PURPOSE DENTAL TRAY	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/10/2011	76OFXGENERAL PURPOSE DENTAL TRAY	118NOT LISTED 290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
11/12/2009	79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED 341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/12/2009	76LCNSCRAPER, TONGUE	118NOT LISTED 341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/12/2009	79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED 341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)

Frequently Asked Questions

What is Y.Z. Corporation's FDA import refusal history?

Y.Z. Corporation (FEI: 3001146947) has 27 FDA import refusal record(s) in our database, spanning from 11/12/2009 to 2/6/2012.

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. Y.Z. Corporation's FEI number is 3001146947.

What types of violations has Y.Z. Corporation received?

Y.Z. Corporation 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 Y.Z. Corporation come from?

All FDA import refusal data for Y.Z. Corporation 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.