Nivico (Private) Ltd.

⚠️ Moderate Risk

FEI: 6793 • Sialkot • PAKISTAN

FEI

FEI Number

6793

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN

🏢

Address

Khadim Ali Road, P.O. Box 194, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

33.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/25/2003

Latest Refusal

11/22/2001

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

33.5×10%

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

1187×

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).

3415×

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).

4802×

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.

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
12/25/2003	80LDQDEVICE, GENERAL MEDICAL	118NOT LISTED 480STAINSTEEL	Chicago District Office (CHI-DO)
12/25/2003	80LDQDEVICE, GENERAL MEDICAL	118NOT LISTED 480STAINSTEEL	Chicago District Office (CHI-DO)
11/22/2001	85HFBFORCEPS, BIOPSY, GYNECOLOGICAL	118NOT LISTED 341REGISTERED 508NO 510(K)	Southwest Import District Office (SWI-DO)
11/22/2001	80FLESTERILIZER, STEAM	118NOT LISTED 341REGISTERED 508NO 510(K)	Southwest Import District Office (SWI-DO)
11/22/2001	85HFBFORCEPS, BIOPSY, GYNECOLOGICAL	118NOT LISTED 341REGISTERED	Southwest Import District Office (SWI-DO)
11/22/2001	80FOBBEDPAN	118NOT LISTED 341REGISTERED	Southwest Import District Office (SWI-DO)
11/22/2001	85HFBFORCEPS, BIOPSY, GYNECOLOGICAL	118NOT LISTED 341REGISTERED	Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Nivico (Private) Ltd.'s FDA import refusal history?

Nivico (Private) Ltd. (FEI: 6793) has 7 FDA import refusal record(s) in our database, spanning from 11/22/2001 to 12/25/2003.

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. Nivico (Private) Ltd.'s FEI number is 6793.

What types of violations has Nivico (Private) Ltd. received?

Nivico (Private) Ltd. 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 Nivico (Private) Ltd. come from?

All FDA import refusal data for Nivico (Private) 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.