Care & Cure Surgico

⚠️ Moderate Risk

FEI: 3003830670 • Sialkot • PAKISTAN

FEI

FEI Number

3003830670

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN

🏢

Address

P.O. Box 919, Roras Road, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

40.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

4/9/2003

Latest Refusal

1/20/2003

Earliest Refusal

Score Breakdown

Violation Severity

48.0×40%

Refusal Volume

38.6×30%

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

1189×

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).

3411×

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).

Refusal History

Date	Product	Violations	Division
4/9/2003	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	118NOT LISTED	New Orleans District Office (NOL-DO)
1/20/2003	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	341REGISTERED	New Orleans District Office (NOL-DO)
1/20/2003	76ELBSCALER, ROTARY	118NOT LISTED	New Orleans District Office (NOL-DO)
1/20/2003	76EKJBURNISHER, OPERATIVE	118NOT LISTED	New Orleans District Office (NOL-DO)
1/20/2003	76EJISYRINGE, CARTRIDGE	118NOT LISTED	New Orleans District Office (NOL-DO)
1/20/2003	76EKRPLUGGER, ROOT CANAL, ENDODONTIC	118NOT LISTED	New Orleans District Office (NOL-DO)
1/20/2003	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED	New Orleans District Office (NOL-DO)
1/20/2003	76EILGAUGE, DEPTH, INSTRUMENT, DENTAL	118NOT LISTED	New Orleans District Office (NOL-DO)
1/20/2003	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED	New Orleans District Office (NOL-DO)
1/20/2003	76EKHCARVER, DENTAL AMALGAM, OPERATIVE	118NOT LISTED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Care & Cure Surgico's FDA import refusal history?

Care & Cure Surgico (FEI: 3003830670) has 10 FDA import refusal record(s) in our database, spanning from 1/20/2003 to 4/9/2003.

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. Care & Cure Surgico's FEI number is 3003830670.

What types of violations has Care & Cure Surgico received?

Care & Cure Surgico 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 Care & Cure Surgico come from?

All FDA import refusal data for Care & Cure Surgico 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.