Amigo Commercial Ways

⚠️ Moderate Risk

FEI: 3003786492 • Karimpura Sialkot • PAKISTAN

FEI

FEI Number

3003786492

📍

Location

Karimpura Sialkot

🇵🇰

Country

PAKISTAN

🏢

Address

Po Box 271, , Karimpura Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

42.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/30/2002

Latest Refusal

9/30/2002

Earliest Refusal

Score Breakdown

Violation Severity

60.0×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

80.0×10%

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

1188×

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).

27808×

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
9/30/2002	76EEFCLAMP, RUBBER DAM	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
9/30/2002	76JEXPLIER, ORTHODONTIC	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
9/30/2002	76EAXMIRROR, MOUTH	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
9/30/2002	76EBLPIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
9/30/2002	76EILGAUGE, DEPTH, INSTRUMENT, DENTAL	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
9/30/2002	76EKRPLUGGER, ROOT CANAL, ENDODONTIC	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
9/30/2002	76EIKCARVER, WAX, DENTAL	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)
9/30/2002	76EGDWAX, DENTAL, INTRAORAL	118NOT LISTED 2780DEVICEGMPS	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Amigo Commercial Ways's FDA import refusal history?

Amigo Commercial Ways (FEI: 3003786492) has 8 FDA import refusal record(s) in our database, spanning from 9/30/2002 to 9/30/2002.

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. Amigo Commercial Ways's FEI number is 3003786492.

What types of violations has Amigo Commercial Ways received?

Amigo Commercial Ways 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 Amigo Commercial Ways come from?

All FDA import refusal data for Amigo Commercial Ways 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.