Mua Ortho Dentics Supply

⚠️ Moderate Risk

FEI: 3003340857 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3003340857

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN

🏢

Address

P.O. Box 2328, Nasir Road, , 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

12/14/2016

Latest Refusal

10/9/2002

Earliest Refusal

Score Breakdown

Violation Severity

64.7×40%

Refusal Volume

59.7×30%

Recency

0.0×20%

Frequency

28.2×10%

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

48026×

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.

34114×

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).

2908×

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).

2235×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

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).

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.

Refusal History

Date	Product	Violations	Division
12/14/2016	77KCNEAR WICK	223FALSE	Division of Northeast Imports (DNEI)
12/14/2016	76EILGAUGE, DEPTH, INSTRUMENT, DENTAL	223FALSE	Division of Northeast Imports (DNEI)
12/14/2016	76EMNSCALER, PERIODONTIC	223FALSE	Division of Northeast Imports (DNEI)
12/14/2016	77KCNEAR WICK	223FALSE	Division of Northeast Imports (DNEI)
12/14/2016	76JEXPLIER, ORTHODONTIC	223FALSE	Division of Northeast Imports (DNEI)
5/13/2015	76JEXPLIER, ORTHODONTIC	290DE IMP GMP	New York District Office (NYK-DO)
5/31/2011	76JEXPLIER, ORTHODONTIC	290DE IMP GMP	Cincinnati District Office (CIN-DO)
5/31/2011	76EMNSCALER, PERIODONTIC	290DE IMP GMP	Cincinnati District Office (CIN-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
8/11/2010	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)
6/15/2009	76EHYTRAY, IMPRESSION, PREFORMED	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/15/2009	79KCXEPILATOR, HIGH FREQUENCY, TWEEZER-TYPE	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/15/2009	76EMNSCALER, PERIODONTIC	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/15/2009	76JEXPLIER, ORTHODONTIC	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/2/2009	76EMNSCALER, PERIODONTIC	480STAINSTEEL	New York District Office (NYK-DO)
6/2/2009	76JEXPLIER, ORTHODONTIC	480STAINSTEEL	New York District Office (NYK-DO)
10/14/2008	79FZTCUTTER, SURGICAL	290DE IMP GMP	Cincinnati District Office (CIN-DO)
6/6/2008	76EIGRETRACTOR, ALL TYPES	118NOT LISTED 2780DEVICEGMPS	New York District Office (NYK-DO)
11/3/2005	76EKHCARVER, DENTAL AMALGAM, OPERATIVE	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	76EMNSCALER, PERIODONTIC	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	79HTDFORCEPS	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	76JEXPLIER, ORTHODONTIC	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	79HTDFORCEPS	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	76EKCEXCAVATOR, DENTAL, OPERATIVE	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	76EKHCARVER, DENTAL AMALGAM, OPERATIVE	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	76EMNSCALER, PERIODONTIC	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	79HTDFORCEPS	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	76JEXPLIER, ORTHODONTIC	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	79HTDFORCEPS	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
11/3/2005	76EKCEXCAVATOR, DENTAL, OPERATIVE	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
10/9/2002	76EJBHANDLE, INSTRUMENT, DENTAL	480STAINSTEEL	New York District Office (NYK-DO)

Frequently Asked Questions

What is Mua Ortho Dentics Supply's FDA import refusal history?

Mua Ortho Dentics Supply (FEI: 3003340857) has 40 FDA import refusal record(s) in our database, spanning from 10/9/2002 to 12/14/2016.

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. Mua Ortho Dentics Supply's FEI number is 3003340857.

What types of violations has Mua Ortho Dentics Supply received?

Mua Ortho Dentics Supply has been cited for 6 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 Mua Ortho Dentics Supply come from?

All FDA import refusal data for Mua Ortho Dentics Supply 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.